Establishment Name
|
Registration Number |
Current Registration Yr |
|
1811755
|
2024
|
|
Manufacturer; Specification Developer
|
|
|
Manufacturer; Specification Developer
|
|
|
|
|
|
|
|
|
|
|
|
|
Manufacturer; Specification Developer
|
|
|
Manufacturer; Specification Developer
|
|
|
|
|
Repackager/Relabeler; Specification Developer
|
|
|
|
|
|
|
Manufacturer; Specification Developer
|
|
|
Manufacturer; Specification Developer
|
|
|
|
|
Manufacturer; Specification Developer
|
|
|
|
|
Manufacturer; Repackager/Relabeler; Specification Developer
|
|
|
|
|
|
|
|
|
|
|
|
|
Manufacturer; Specification Developer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Manufacturer; Specification Developer
|
|
|
Manufacturer; Specification Developer
|
|
|
|
|
|
|
Specification Developer; Complaint File Establishment
|
|
|
|
|
Manufacturer; Specification Developer
|
|
|
Manufacturer; Specification Developer
|
|
|
|
|
|
|
|
|
|
|
Manufacturer; Specification Developer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Manufacturer; Specification Developer
|
|
|
|
|
Manufacturer; Specification Developer
|
|
|
|
|
Manufacturer; Specification Developer
|
|
|
|
|
|
|
|
|
|
|
Specification Developer; Complaint File Establishment
|
|
|
Specification Developer; Complaint File Establishment
|
|
|
|
|
|
|
Repackager/Relabeler; Specification Developer
|
|
|
Manufacturer; Specification Developer
|
|
|
Manufacturer; Specification Developer
|
|
|
|
|
|
|
|
|
Manufacturer; Specification Developer
|
|
|
Manufacturer; Specification Developer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Manufacturer; Specification Developer
|
|
|
|
|
Specification Developer; Complaint File Establishment
|
|
|
Specification Developer; Complaint File Establishment
|
|
|
Specification Developer; Complaint File Establishment
|
|
|
Specification Developer; Complaint File Establishment
|
|
|
|
|
|
|
Specification Developer; Complaint File Establishment
|
|
|
Specification Developer; Complaint File Establishment
|
|
|
Specification Developer; Complaint File Establishment
|
|
|
Specification Developer; Complaint File Establishment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Manufacturer; Specification Developer
|
|
|
|
-
orthopedic manual surgical instrument
-
10.0mm SUBFIX TRIAL; 11.5mm SUBFIX TRIAL; 206-716 w/2 small sculps/pkg; 3MM DBL SLEEVE 80MM TROC/ASSY; 3mm PREDRILL ASSEMBLY LONG; 3mm PREDRILL ASSEMBLY SHORT; 4mm DBL SLEEVE 150mm TROC/ASSY; 4MM DBL SLVE 180MM TROC/ASSY; 4mm PREDRILL ASSEMBLY EXTRA SHORT; 4mm PREDRILL ASSEMBLY LONG; 4mm PREDRILL ASSEMBLY SHORT; 5mm PREDRILL ASSEMBLY EXTRA SHORT; 5mm PREDRILL ASSEMBLY LONG; 5mm PREDRILL ASSEMBLY SHORT; 5mm SPANNER WRENCH; 6.5mm SUBFIX TRIAL; 6mm PREDRILL ASSEMBLY EXTRA SHORT; 6mm PREDRILL ASSEMBLY LONG; 6mm PREDRILL ASSEMBLY SHORT; 7MM SPANNER WRENCH; 8.0mm SUBFIX TRIAL; 9.0mm SUBFIX TRIAL; A 2 DRILL BRACE W/O CHUCK; A 4 4MM CHUCK; A 5 T-WRENCH; A 51 T WRENCH W/35 EXTENSION; Accolade II System Instrumentation; ACL Workstation; AGM 6 6MM CHUCK; Aleutian, Ari, Blue Ridge, Canyon, Capri, Cascadia, Caspian, Chesapeake, Cayman, Cayman MI, Denali MI, Denali, Everest; All OrthoHelix Orthopedic Manual Surgical Instruments; All Tornier Orthopeadic Manual Surgical Instruments (exempt); Anato Hip System Instrumentation; Anatomic Express Tray; ANCHORAGE CP INSTRUMENTS SILICONE SUPPORT (WITHOUT INSTRUMENTS); ANCHORAGE CP LAPIDUS PIVOTING DRILL GUIDE; ANCHORAGE CP LAPIDUS TEMPLATE; ANCHORAGE CP MTP PIVOTING DRILL GUIDE; ANCHORAGE CP MTP TEMPLATE; ANCHORAGE CP POLYAXIAL DRILL GUIDE; ANCHORAGE CP UTILITY TEMPLATE; ANCHORAGE FIXATION PIN; ANCHORAGE FIXED DRILL GUIDE 2.5MM; ANCHORAGE FIXED DRILL GUIDE 2MM; ANCHORAGE INSTRUMENTS RACK (LEVEL 1); ANCHORAGE INSTRUMENTS RACK (LEVEL 2); ANCHORAGE INSTRUMENTS RACK COVER; ANCHORAGE PLATE BENDER; ANCHORAGE PLATE GRIPPER; AO HANDLE - LENGTH 135MM; AO Quick Coupling with Elastosil Handle; AO/JACOBS QUICK RELEASE APEX CHUCK 3mm; AO/JACOBS QUICK RELEASE APEX CHUCK 4mm; AO/JACOBS QUICK RELEASE APEX CHUCK 5mm; AO/JACOBS QUICK RELEASE APEX CHUCK 6mm; APEX DRILL BRACE - 3/4/5/6mm; APEX DRILL GUIDE HANDLE; APEX TRAY BASE; APEX TRAY LID; APEX TRAY LOWER INSERT; APEX TRAY UPPER INSERT; Asnis® III Cannulated Screw System; Asnis® PRO Cannulated Screw System; ATP Disc Prep; AxSOS; AxSOS 3; AxSOS 3 AF System and AxSOS 3 Ti System, Plate; AxSOS 3 Ankle Fusion; AxSOS 3 Ti; AXSOS ADAPTOR FOR TORQUE TESTER T20; AXSOS ADAPTOR FOR TORQUE TESTER T8/T15; AXSOS SPARE SET SCREW/FEMUR AIMING BLOCK; BARREL REAMER ASSEMBLY STAND; BIOCOMPRESSION WRENCH 15mm TUBE; BIOCOMPRESSION WRENCH 20mm TUBE; BIOCOMPRESSION WRENCH 25mm TUBE; Biosteon Wedge Interference Screw System; Bixcut, IM Reamer; Bone Plug Extractor; BriteField Depth Gauge; Broach and Inserter Handle; CalcLock manual surgical instruments; Cannulated Countersink with AO Fitting; Cannulated Drill ø 2,7/3.5mm with AO Fitting; Cannulated Drill with AO Fitting; Cannulated Screwdriver with AO Fitting; Cannulated Screwdriver with Elastosil Handle; Cannulated Tap with AO Fitting; Cascadia Interbody System; Colored Plugs; Counterbore Drill; CUTTING SCREWDRIVER 4.5; CYLINDRICAL BUSH HOLDER; DEPTH GAUGE; DEPTH GAUGE (DISTAL RADIUS); Depth Gauge (Foot/Elbow/Distal Fib); DEPTH GAUGE (HAND); Direct Measuring Gauge; DISPOSABLE CEMENT SCULPS; DJD II STORAGE CASE; Double Drill Guide ø 2,0/3,5mm; Drill Bit; Drill Bit ø 2,0 x 150mm; DRILL GUIDE BLOCK COMPACT 4 HOLE; DRILL GUIDE BLOCK COMPACT PERI 4 HOLE; DRILL GUIDE BLOCK HII 10 HOLE; DRILL GUIDE BLOCK HII 5 HOLE; DRILL GUIDE BLOCK MONOTUBE 4 HOLE; DRILL GUIDE BLOCK YLW MONOTUBE 2 HOLE; DRILL GUIDE LOCK II 2.5; Drill Sleeve; Dual-sided Baseplate Centering Guide; EASY CLIP ANGLED DRILL GUIDE SIZE 15; Edgelock manual surgical instruments; Elastosil T-Handle with AO Coupling; Exeter Hip System Instrumentation; Express Humeral Stem Extractor; Express Insert; extraction shaft; Extractor for Screws; Extractor Rod; FEMORAL CANAL BRUSH, STANDARD; FIXOS 4.0 MV DEPTH GAUGE; General Instruments; GUIDE FOR HALF-PINS; Guide Wire; Guide Wire Pusher; Guide Wire Ruler; Guide Wire Targeter; Guide Wire Targeter - Crown; Guide Wire Targeter - Sleeve; Guide Wire, Threaded; HII 7mm T-WRENCH / 5+6mm SOCKET; HII COMPACT 5mm WRENCH/3&4mm SOCKET; HII COMPACT GUIDE BLOCK W/AO; HII COMPACT MRI STORAGE CASE BASE; HII COMPACT MRI STORAGE CASE LID; HII COMPACT MRI STORAGE CASE UPPER INSERT; HII COMPACT STORAGE CASE BASE; HII COMPACT STORAGE CASE LID; HII COMPACT STORAGE CASE UPPER INSERT; HII MICRO 2mm PIN DRIVER; HII MICRO DRILL GUIDE ASSEMBLY; HII MICRO NUT DRIVER; HII MICRO STORAGE CASE BASE; HII MICRO STORAGE CASE DRILL BIT HOLDER; HII MICRO STORAGE CASE LID; HII MICRO STORAGE CASE LOWER INSERT; HII MICRO STORAGE CASE UPPER INSERT; HII MRI TRAY BASE; HII MRI TRAY LID; HII MRI TRAY LOWER INSERT; HII TRAY BASE; HII TRAY LID; HII TRAY LOWER INSERT; HII TRAY UPPER INSERT; HM MINI 4.0 SPANNER WRENCH; HOFFMANN LRF INFO BOARD; HOFFMANN LRF INSTRUMENTS AND IMPLANTS INSERT; HOFFMANN LRF INSTRUMENTS AND IMPLANTS TRAY; HOFFMANN LRF RATCHET WRENCH - HEX 10; HOFFMANN LRF SPANNER WRENCH - 5 mm; HOFFMANN LRF SPANNER WRENCH - 7/10 mm; Hoffmann LRF System, Insert; Hoffmann LRF System, Instrument; Hoffmann LRF System, Ruler; Hoffmann LRF System, Wire Tensioner; Hoffmann LRF System, Wrench; HOFFMANN LRF TELES. STRUT WRENCH; HOFFMANN LRF THUMBWHEEL - HEX 10; HOFFMANN LRF THUMBWHEEL FOR TELESCOPIC STRUTS; HOFFMANN LRF UNIVERSAL COMPONENTS INSERT; HOFFMANN LRF UNIVERSAL COMPONENTS TRAY; HOFFMANN LRF WIRE BOLT WRENCH; HOFFMANN LRF WIRE TENS. NOSE - LONG; HOFFMANN LRF WIRE TENS. NOSE - SHORT; HOFFMANN LRF WIRE TENSIONER; HOFFMANN XPRESS SILICON MAT; HOFFMANN XPRESS SILICON THUMBWHEEL; HOFFMANN XPRESS SPANNER WRENCH; HOFFMANN XPRESS STORAGE CASE BASE; HOFFMANN XPRESS STORAGE CASE INSERT; HOFFMANN XPRESS STORAGE CASE LID; HOFFMANN XPRESS TORQUE WRENCH; HOFFMANN3 TRAY FOR STANDARD COMPOMENTS; Holding Sleeve; HOLDING SPANNER 4.5; Humeral Express Tray; INCLINED DRILL GUIDE SCREW EZ18; INCLINED DRILLING GUIDE + SCREW EZ20; Insertion Sleeve for Guide Wire; INSTRUMENT TRAY BASE 4.5; INSTRUMENT TRAY LID FIXOS; INTRAMEDULLARY BRUSH STANDARD 14MM OD; Intraosseous Fixation system manual surgical instruments; KW BENDING IRON ICS; lag screw driver; lag screw reamer; Lag Screw Sleeve; Large AO Coupling - Hall Fitting; LID FOR INSTRUMENT TRAY; LID FOR PLATE RACK - COMPRESSION PLATES; LID FOR PLATE RACK - GENERIC; LID FOR PLATE RACK - SPECIAL PLATES; LITe BIO Delivery System - Sterilization Tray and Lid; M/T TRIAX LNG HANDLE WRENCH BLUE; M/T TRIAX LNG HANDLE WRENCH RED; M/T TRIAX LNG HANDLE WRENCH YELLOW; MaxLock Extreme manual surgical instruments; Meniscal Transplant Set; Mesa, Mesa Small Stature, Napa MI, Nile Alternative, Nile, Pyrenees, Santorini; MILITARY EXTERNAL FIXATION CASE; Mini MaxLock manual surgical instruments; Modular Glenoid Surface Trial; Modular Humeral Head Trial; Modular Humeral Head Trial Post; MONOTUBE TRIAX YELLOW CASE; Multiple Drill Guide; NAPA Access System; OBLONG DRILL GUIDE DIAMETER 2MM; OMEGA PLUS 145 DRILL GUIDE INSERT; OMEGA PLUS DRILL GUIDE 3.2mm DIA-1mm COMPRESSION; OMEGA PLUS DRILL GUIDE 3.2mm DIA-2mm COMPRESSION; OMEGA PLUS DRILL GUIDE 3.6mm DIA-COMPRESSION; OMEGA PLUS DRILL GUIDE 3.6mm DIA-NEUTRAL; OMEGA PLUS DRILL GUIDE HANDLE; OMEGA PLUS HEAD; OMEGA PLUS HEX POWERBIT W/TRKLE END 3.5mm; OMEGA PLUS LAG SCREW ADAPTER; OMEGA PLUS SCREW EXTRACTION BOLT; OMEGA PLUS SUPRACONDYLAR DRILL GUIDE; OMEGA PLUS SUPRACONDYLAR PIN GUIDE; OMEGA PLUS TAP GUIDE 4.5mm; OMEGA PLUS TAP GUIDE 6.5mm; OMEGA PLUS TRIAL PLATE 150; OMEGA+ BARREL REAM ASSY SHORT; OMEGA+ PIN W/THREAD 2.8X230MM; OMEGA+ VAR ANGLE GUID REPL KIT; Opening Guide; Opening Reamer; Opening Sleeve; Orthopaedic Manual Instrumentation; ORTHOPEDIC MANUAL; Overdrill for 4.5mm Screws, AO; Pangea Platform; Parallel Guide for ø 1,4mm/2.0mm Wires; PEDIATRIC CORTICAL REAMER; Percutaneous guide wire inserter; PeriPROTM Femur; PIN CUTTER / HA PINS; Plastic Tray; PLATE BENDING IRONS; Posterior TLIF; precision pin; precision sleeve; PRO Plating System; Quick Release Driver Hall Fitting; RACK FOR OPEN WEDGE PLATES (LEVEL 2); RACK FOR PLP UTILITY/MTP (LEVEL 2); RACK FOR UTILITY/LISFRANC PLATES (LEVEL 2); RED & BLUE INTL M/T CASE; REDUCTION HANDLES B & R CLAMPS; Reduction Tray; Reduction Tray generic Insert; Reduction Tray Insert for Jaw Clamps; Reduction Tray Insert for Weber Clamps; REPLACEMENT COMPONENTS; REPLACEMENT KNOB FOR DRILL BRACE; Restoration ADM/MDM Instrumentation; Reverse Express Tray; RING DRIVER 4.5; SCREW CADDY FOR 2.0 / 2.5 FIXO TRAY; screw depth gauge; Screw Holder; Screw Insertion Sleeve; SCREW RACK ANCHORAGE; SCREW RACK WS + CS (2.0MM+3.5MM); SCREW TRAY 4.5; SCREW-HOLDING FORCEPS FIXOS; Screwdriver Blade, AO, T10; SET ANCILLARY IMPLANT SUBTALAR; set screw driver; SET SCREW FOR HUMERUS AIMING BLOCK; SET SCREW FOR TIBIA AIMING BLOCK; Silicon Mat, Generic Insert; Silicon Mat, Insert for Jaw Clamps; Silicon Mat, Insert for Weber Clamps; SILICONE MAT; SMALL RULER FOR MEASUREMNET; SMART TOE 1 INSTRUMENT KIT; Solid Screwdriver with AO Fitting; SPARE SET SCREW HUMERUS TS AIMING BLOCK; SPARE SHAFT TEMP. PLATE HOLDER; SPIKE SCREW INSERTER FOR 4.5MM SCREWS; SPS BENDING SLEEVE - SLOTTED STEEL; STANDARD BENDING SLEEVE; STANDARD DRILL GUIDE ANCHORAGE DIAMETER 2.5MM; STANDARD DRILL GUIDE ANCHORAGE DIAMETER 2MM; Stanmore Face Cutter and Alignment Tool; STRAIGHT FEMORAL CANAL BRUSH; Stryker Trauma Pelvic Set (Matta); Stylet; SUBFIX INSERTION INSTRUMENT; T-HANDLE PIN INSERTER; T2 Alpha Femur Retrograde Nailing System, Nail Adapter SPI; T2 Alpha Femur Retrograde Nailing System, Nail Holding Screw SPI; T2 Alpha Femur Retrograde Nailing System, Target Device; T2 Alpha Femur Retrograde Nailing System, Tissue Protection Sleeve; TENSION DEVICE 16MM; Terra Nova, Ravine, Serengeti, VCR, Cricket; Threaded Guide Wire; Tissue Protection Sleeve; Tornier Extraction; TRAY; Tray - Silicon Mat; tray base; TRAY FOR MV SCREWS; Tray insert; TRIAL ANCHORAGE PLP10341; TRIAL ANCHORAGE PLP10342; TRIAL ANCHORAGE PLP10461; TRIAL ANCHORAGE PLP10462; TRIAL ANCHORAGE PLP11341; TRIAL ANCHORAGE PLP11342; TRIAL ANCHORAGE PLP30141; TRIAL ANCHORAGE PLP30142; TRIAL ANCHORAGE PLP30171; TRIAL ANCHORAGE PLP30172; TRIAL ANCHORAGE PLP30201; TRIAL ANCHORAGE PLP30202; TRIAL ANCHORAGE PLP40160; TRIAL ANCHORAGE PLP40220; TRIAL ANCHORAGE PLP40280; TRIAL ANCHORAGE PLP40340; TRIAL ANCHORAGE PLP40400; TRIAL ANCHORAGE PLP40460; Trocar; TwinLoop Anchor System; Twist-drill cannulated ø8.0/L300mm; Universal ACL Instrumentation; UNIVERSAL BENDING SLEEVE; UNIVERSAL PIN-WIRE CASE; UniVise; Variable Angle Fixation; VariAx 2 Compression Plating System, Plate Insert; VariAx 2 Compression Plating System, Plate Trial; VariAx 2 foot, Depth Gauge; VariAx 2 Foot, Drawer; VariAx 2 Foot, Insert; VariAx 2 Foot, Instrument Kit; VariAx 2 Foot, Labeling Clip; VariAx 2 Foot, Module; VariAx 2 Foot, Module Lid; VariAx 2 Foot, Screw Rack; VariAx 2 Foot, Tap for 2.7mm screws; VariAx 2, Aiming Block Fixation Pin; VariAx 2, Clip; VariAx 2, Depth Gauge; VariAx 2, Distal Radius Container Half-Size; VariAx 2, Distal Radius Implant Module; VariAx 2, Drill Bit; VariAx 2, Drill Guide K-Wire; VariAx 2, Fixed Angle Drill Guide 2.3/2.7mm; VariAx 2, Handle With 2.3mm Drill And K-Wire Guide; VariAx 2, Handle With Drill Guides; VariAx 2, Inlay; VariAx 2, Insert; VariAx 2, Joystick; VariAX 2, Lid For Sterilizing Container; VariAx 2, Pliers; VariAx 2, Reduction Instrument Insert; VariAx 2, Screw Rack; VariAx 2, Screw Rack Locking Screws; VariAx 2, Screw Rack Non-Locking Screws; VariAx 2, ScrewDriver Blade; Variax 2, Steinmann Pin; VariAx 2, Tap For 2.7mm Screws; VariAx Foot, Countersink; VariAx Foot, Holding Sleeve; VariAx, Drill; VariAx, Drill Guide; VariAx, Handle; VariAx, Safety Shield; VariAx, Screw Length Marker; VariAx, Screwdriver; VariAx, Tension Plier; VariAx, Tension Sheath; VariAx, Trial
|
|
|
Manufacturer; Specification Developer
|
|
|
|
|
Specification Developer; Complaint File Establishment
|
|
|
Specification Developer; Complaint File Establishment
|
|
|
Specification Developer; Complaint File Establishment
|
|
|
Specification Developer; Complaint File Establishment
|
|
|
Specification Developer; Complaint File Establishment
|
|