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Product Code : MAX

Establishment
Name

Registration Number

Current
Registration Yr

AR FABRICATING

TX/USA

3010143171

2013

intervertebral fusion device with bone graft, lumbar - Great White; Shark; Thresher; TigerShark

Manufacturer

ATLAS SPINE INC.

FL/USA

3003855635

2013

intervertebral fusion device with bone graft, lumbar - Stature® Peek Spacer System

Manufacturer; Reprocessor of Single Use Devices; Specification Developer; Complaint File Establishment

intervertebral fusion device with bone graft, lumbar - True Position® Pivoting Spacer System

Manufacturer; Repackager/Relabeler; Specification Developer; Complaint File Establishment

B & G MFG. CO.

PA/USA

3004188066

2013

intervertebral fusion device with bone graft, lumbar

Contract Manufacturer

BANISTER TOOL, INC.

TX/USA

1649379

2013

intervertebral fusion device with bone graft, lumbar - Spine Smith 0301-0805 VisuALIF: Small 25mm x 32mm PEEK Implant: 8mm x 5°; Spine Smith 0301-0810 VisuALIF: Small 25mm x 32mm PEEK Implant: 8mm x 10°; Spine Smith 0301-0815 VisuALIF: Small 25mm x 32mm PEEK Implant: 8mm x 15°; Spine Smith 0301-0820 VisuALIF: Small 25mm x 32mm PEEK Implant: 8mm x 20°; Spine Smith 0301-1005 VisuALIF: Small 25mm x 32mm PEEK Implant: 10mm x 5°; Spine Smith 0301-1010 VisuALIF: Small 25mm x 32mm PEEK Implant: 10mm x 10°; Spine Smith 0301-1015 VisuALIF: Small 25mm x 32mm PEEK Implant: 10mm x 15°; Spine Smith 0301-1020 VisuALIF: Small 25mm x 32mm PEEK Implant: 10mm x 20°; Spine Smith 0301-1205 VisuALIF: Small 25mm x 32mm PEEK Implant: 12mm x 5°; Spine Smith 0301-1210 VisuALIF: Small 25mm x 32mm PEEK Implant: 12mm x 10°; Spine Smith 0301-1215 VisuALIF: Small 25mm x 32mm PEEK Implant: 12mm x 15°; Spine Smith 0301-1220 VisuALIF: Small 25mm x 32mm PEEK Implant: 12mm x 20°; Spine Smith 0301-1405 VisuALIF: Small 25mm x 32mm PEEK Implant: 14mm x 5°; Spine Smith 0301-1410 VisuALIF: Small 25mm x 32mm PEEK Implant: 14mm x 10°; Spine Smith 0301-1415 VisuALIF: Small 25mm x 32mm PEEK Implant: 14mm x 15°; Spine Smith 0301-1420 VisuALIF: Small 25mm x 32mm PEEK Implant: 14mm x 20°; Spine Smith 0302-0805 VisuALIF: Medium 29mm x 36mm PEEK Implant: 8mm x 5°; Spine Smith 0302-0810 VisuALIF: Medium 29mm x 36mm PEEK Implant: 8mm x 10°; Spine Smith 0302-0815 VisuALIF: Medium 29mm x 36mm PEEK Implant: 8mm x 15°; Spine Smith 0302-0820 VisuALIF: Medium 29mm x 36mm PEEK Implant: 8mm x 20°; Spine Smith 0302-1005 VisuALIF: Medium 29mm x 36mm PEEK Implant: 10mm x 5°; Spine Smith 0302-1010 VisuALIF: Medium 29mm x 36mm PEEK Implant: 10mm x 10°; Spine Smith 0302-1015 VisuALIF: Medium 29mm x 36mm PEEK Implant: 10mm x 15°; Spine Smith 0302-1020 VisuALIF: Medium 29mm x 36mm PEEK Implant: 10mm x 20°; Spine Smith 0302-1205 VisuALIF: Medium 29mm x 36mm PEEK Implant: 12mm x 5°; Spine Smith 0302-1210 VisuALIF: Medium 29mm x 36mm PEEK Implant: 12mm x 10°; Spine Smith 0302-1215 VisuALIF: Medium 29mm x 36mm PEEK Implant: 12mm x 15°; Spine Smith 0302-1220 VisuALIF: Medium 29mm x 36mm PEEK Implant: 12mm x 20°; Spine Smith 0302-1405 VisuALIF: Medium 29mm x 36mm PEEK Implant: 14mm x 5°; Spine Smith 0302-1410 VisuALIF: Medium 29mm x 36mm PEEK Implant: 14mm x 10°; Spine Smith 0302-1415 VisuALIF: Medium 29mm x 36mm PEEK Implant: 14mm x 15°; Spine Smith 0302-1420 VisuALIF: Medium 29mm x 36mm PEEK Implant: 14mm x 20°; Spine Smith 0303-0805 VisuALIF: Large 29mm x 42mm PEEK Implant: 8mm x 5°; Spine Smith 0303-0810 VisuALIF: Large 29mm x 42mm PEEK Implant: 8mm x 10°; Spine Smith 0303-0815 VisuALIF: Large 29mm x 42mm PEEK Implant: 8mm x 15°; Spine Smith 0303-0820 VisuALIF: Large 29mm x 42mm PEEK Implant: 8mm x 20°; Spine Smith 0303-1005 VisuALIF: Large 29mm x 42mm PEEK Implant: 10mm x 5°; Spine Smith 0303-1010 VisuALIF: Large 29mm x 42mm PEEK Implant: 10mm x 10°; Spine Smith 0303-1015 VisuALIF: Large 29mm x 42mm PEEK Implant: 10mm x 15°; Spine Smith 0303-1020 VisuALIF: Large 29mm x 42mm PEEK Implant: 10mm x 20°; Spine Smith 0303-1205 VisuALIF: Large 29mm x 42mm PEEK Implant: 12mm x 5°; Spine Smith 0303-1210 VisuALIF: Large 29mm x 42mm PEEK Implant: 12mm x 10°; Spine Smith 0303-1215 VisuALIF: Large 29mm x 42mm PEEK Implant: 12mm x 15°; Spine Smith 0303-1220 VisuALIF: Large 29mm x 42mm PEEK Implant: 12mm x 20°; Spine Smith 0303-1405 VisuALIF: Large 29mm x 42mm PEEK Implant: 14mm x 5°; Spine Smith 0303-1410 VisuALIF: Large 29mm x 42mm PEEK Implant: 14mm x 10°; Spine Smith 0303-1415 VisuALIF: Large 29mm x 42mm PEEK Implant: 14mm x 15°; Spine Smith 0306-5523 VisuALIF: 5.5mm x 23mm Constrained Bone Screw; Spine Smith 0306-5525 VisuALIF: 5.5mm x 25mm Constrained Bone Screw; Spine Smith 0306-5528 VisuALIF: 5.5mm x 28mm Constrained Bone Screw; Spine Smith 0306-5533 VisuALIF: 5.5mm x 33mm Constrained Bone Screw

Contract Manufacturer

intervertebral fusion device with bone graft, lumbar - Spine Smith 0601-0080 Cynch TLIF: 5° x 11mm x 30mm x 8mm; Spine Smith 0601-0090 Cynch TLIF: 5° x 11mm x 30mm x 9mm; Spine Smith 0601-0100 Cynch TLIF: 5° x 11mm x 30mm x 10mm; Spine Smith 0601-0110 Cynch TLIF: 5° x 11mm x 30mm x 11mm; Spine Smith 0601-0120 Cynch TLIF: 5° x 11mm x 30mm x 12mm; Spine Smith 0601-0130 Cynch TLIF: 5° x 11mm x 30mm x 13mm; Spine Smith 0601-0140 Cynch TLIF: 5° x 11mm x 30mm x 14mm; Spine Smith 0601-0150 Cynch TLIF: 5° x 11mm x 30mm x 15mm; Spine Smith 0602-0060 Cynch TLIF: 5° x 11mm x 25mm x 6mm; Spine Smith 0602-0070 Cynch TLIF: 5° x 11mm x 25mm x 7mm; Spine Smith 0602-0080 Cynch TLIF: 5° x 11mm x 25mm x 8mm; Spine Smith 0602-0090 Cynch TLIF: 5° x 11mm x 25mm x 9mm; Spine Smith 0602-0100 Cynch TLIF: 5° x 11mm x 25mm x 10mm; Spine Smith 0602-0110 Cynch TLIF: 5° x 11mm x 25mm x 11mm; Spine Smith 0602-0120 Cynch TLIF: 5° x 11mm x 25mm x 12mm; Spine Smith 0602-0130 Cynch TLIF: 5° x 11mm x 25mm x 13mm; Spine Smith 0602-0140 Cynch TLIF: 5° x 11mm x 25mm x 14mm; Spine Smith 0602-0150 Cynch TLIF: 5° x 11mm x 25mm x 15mm; Spine Smith 0609-2307-06 Cynch Lordotic TPLIF: 9mm x 23mm x 7mm x 6°; Spine Smith 0609-2308 Cynch Straight TPLIF: 9mm x 23mm x 8mm; Spine Smith 0609-2308-06 Cynch Lordotic TPLIF: 9mm x 23mm x 8mm x 6°; Spine Smith 0609-2309 Cynch Straight TPLIF: 9mm x 23mm x 9mm; Spine Smith 0609-2309-06 Cynch Lordotic TPLIF: 9mm x 23mm x 9mm x 6°; Spine Smith 0609-2310 Cynch Straight TPLIF: 9mm x 23mm x 10mm; Spine Smith 0609-2310-06 Cynch Lordotic TPLIF: 9mm x 23mm x 10mm x 6°; Spine Smith 0609-2311 Cynch Straight TPLIF: 9mm x 23mm x 11mm; Spine Smith 0609-2311-06 Cynch Lordotic TPLIF: 9mm x 23mm x 11mm x 6°; Spine Smith 0609-2312 Cynch Straight TPLIF: 9mm x 23mm x 12mm; Spine Smith 0609-2312-06 Cynch Lordotic TPLIF: 9mm x 23mm x 12mm x 6°; Spine Smith 0609-2313 Cynch Straight TPLIF: 9mm x 23mm x 13mm; Spine Smith 0609-2313-06 Cynch Lordotic TPLIF: 9mm x 23mm x 13mm x 6°; Spine Smith 0609-2314 Cynch Straight TPLIF: 9mm x 23mm x 14mm; Spine Smith 0609-2314-06 Cynch Lordotic TPLIF: 9mm x 23mm x 14mm x 6°; Spine Smith 0609-2315 Cynch Straight TPLIF: 9mm x 23mm x 15mm; Spine Smith 0609-2315-06 Cynch Lordotic TPLIF: 9mm x 23mm x 15mm x 6°; Spine Smith 0609-2807 Cynch Straight TPLIF: 9mm x 28mm x 7mm; Spine Smith 0609-2807-06 Cynch Lordotic TPLIF: 9mm x 28mm x 7mm x 6°; Spine Smith 0609-2808 Cynch Straight TPLIF: 9mm x 28mm x 8mm; Spine Smith 0609-2808-06 Cynch Lordotic TPLIF: 9mm x 28mm x 8mm x 6°; Spine Smith 0609-2809 Cynch Straight TPLIF: 9mm x 28mm x 9mm; Spine Smith 0609-2809-06 Cynch Lordotic TPLIF: 9mm x 28mm x 9mm x 6°; Spine Smith 0609-2810 Cynch Straight TPLIF: 9mm x 28mm x 10mm; Spine Smith 0609-2810-06 Cynch Lordotic TPLIF: 9mm x 28mm x 10mm x 6°; Spine Smith 0609-2811 Cynch Straight TPLIF: 9mm x 28mm x 11mm; Spine Smith 0609-2811-06 Cynch Lordotic TPLIF: 9mm x 28mm x 11mm x 6°; Spine Smith 0609-2812 Cynch Straight TPLIF: 9mm x 28mm x 12mm; Spine Smith 0609-2812-06 Cynch Lordotic TPLIF: 9mm x 28mm x 12mm x 6°; Spine Smith 0609-2813 Cynch Straight TPLIF: 9mm x 28mm x 13mm; Spine Smith 0609-2813-06 Cynch Lordotic TPLIF: 9mm x 28mm x 13mm x 6°; Spine Smith 0609-2814 Cynch Straight TPLIF: 9mm x 28mm x 14mm; Spine Smith 0609-2814-06 Cynch Lordotic TPLIF: 9mm x 28mm x 14mm x 6°; Spine Smith 0609-2815 Cynch Straight TPLIF: 9mm x 28mm x 15mm; Spine Smith 0609-2815-06 Cynch Lordotic TPLIF: 9mm x 28mm x 15mm x 6°; Spine Smith 0609-3307 Cynch Straight TPLIF: 9mm x 33mm x 7mm; Spine Smith 0609-3307-06 Cynch Lordotic TPLIF: 9mm x 33mm x 7mm x 6°; Spine Smith 0609-3308 Cynch Straight TPLIF: 9mm x 33mm x 8mm; Spine Smith 0609-3308-06 Cynch Lordotic TPLIF: 9mm x 33mm x 8mm x 6°; Spine Smith 0609-3309 Cynch Straight TPLIF: 9mm x 33mm x 9mm; Spine Smith 0609-3309-06 Cynch Lordotic TPLIF: 9mm x 33mm x 9mm x 6°; Spine Smith 0609-3310 Cynch Straight TPLIF: 9mm x 33mm x 10mm; Spine Smith 0609-3310-06 Cynch Lordotic TPLIF: 9mm x 33mm x 10mm x 6°; Spine Smith 0609-3311 Cynch Straight TPLIF: 9mm x 33mm x 11mm; Spine Smith 0609-3311-06 Cynch Lordotic TPLIF: 9mm x 33mm x 11mm x 6°; Spine Smith 0609-3312 Cynch Straight TPLIF: 9mm x 33mm x 12mm; Spine Smith 0609-3312-06 Cynch Lordotic TPLIF: 9mm x 33mm x 12mm x 6°; Spine Smith 0609-3313 Cynch Straight TPLIF: 9mm x 33mm x 13mm; Spine Smith 0609-3313-06 Cynch Lordotic TPLIF: 9mm x 33mm x 13mm x 6°; Spine Smith 0609-3314 Cynch Straight TPLIF: 9mm x 33mm x 14mm; Spine Smith 0609-3314-06 Cynch Lordotic TPLIF: 9mm x 33mm x 14mm x 6°; Spine Smith 0609-3315 Cynch Straight TPLIF: 9mm x 33mm x 15mm; Spine Smith 0609-3315-06 Cynch Lordotic TPLIF: 9mm x 33mm x 15mm x 6°; Spine Smith 0611-2307-06 Cynch Lordotic TPLIF: 11mm x 23mm x 7mm x 6°; Spine Smith 0611-2308 Cynch Straight TPLIF: 11mm x 23mm x 8mm; Spine Smith 0611-2308-06 Cynch Lordotic TPLIF: 11mm x 23mm x 8mm x 6°; Spine Smith 0611-2309 Cynch Straight TPLIF: 11mm x 23mm x 9mm; Spine Smith 0611-2309-06 Cynch Lordotic TPLIF: 11mm x 23mm x 9mm x 6°; Spine Smith 0611-2310 Cynch Straight TPLIF: 11mm x 23mm x 10mm; Spine Smith 0611-2310-06 Cynch Lordotic TPLIF: 11mm x 23mm x 10mm x 6°; Spine Smith 0611-2311 Cynch Straight TPLIF: 11mm x 23mm x 11mm; Spine Smith 0611-2311-06 Cynch Lordotic TPLIF: 11mm x 23mm x 11mm x 6°; Spine Smith 0611-2312 Cynch Straight TPLIF: 11mm x 23mm x 12mm; Spine Smith 0611-2312-06 Cynch Lordotic TPLIF: 11mm x 23mm x 12mm x 6°; Spine Smith 0611-2313 Cynch Straight TPLIF: 11mm x 23mm x 13mm; Spine Smith 0611-2313-06 Cynch Lordotic TPLIF: 11mm x 23mm x 13mm x 6°; Spine Smith 0611-2314 Cynch Straight TPLIF: 11mm x 23mm x 14mm; Spine Smith 0611-2314-06 Cynch Lordotic TPLIF: 11mm x 23mm x 14mm x 6°; Spine Smith 0611-2315 Cynch Straight TPLIF: 11mm x 23mm x 15mm; Spine Smith 0611-2315-06 Cynch Lordotic TPLIF: 11mm x 23mm x 15mm x 6°; Spine Smith 0611-2807-06 Cynch Lordotic TPLIF: 11mm x 28mm x 7mm x 6°; Spine Smith 0611-2808 Cynch Straight TPLIF: 11mm x 28mm x 8mm; Spine Smith 0611-2808-06 Cynch Lordotic TPLIF: 11mm x 28mm x 8mm x 6°; Spine Smith 0611-2809 Cynch Straight TPLIF: 11mm x 28mm x 9mm; Spine Smith 0611-2809-06 Cynch Lordotic TPLIF: 11mm x 28mm x 9mm x 6°; Spine Smith 0611-2810 Cynch Straight TPLIF: 11mm x 28mm x 10mm; Spine Smith 0611-2810-06 Cynch Lordotic TPLIF: 11mm x 28mm x 10mm x 6°; Spine Smith 0611-2811 Cynch Straight TPLIF: 11mm x 28mm x 11mm; Spine Smith 0611-2811-06 Cynch Lordotic TPLIF: 11mm x 28mm x 11mm x 6°; Spine Smith 0611-2812 Cynch Straight TPLIF: 11mm x 28mm x 12mm; Spine Smith 0611-2812-06 Cynch Lordotic TPLIF: 11mm x 28mm x 12mm x 6°; Spine Smith 0611-2813 Cynch Straight TPLIF: 11mm x 28mm x 13mm; Spine Smith 0611-2813-06 Cynch Lordotic TPLIF: 11mm x 28mm x 13mm x 6°; Spine Smith 0611-2814 Cynch Straight TPLIF: 11mm x 28mm x 14mm; Spine Smith 0611-2814-06 Cynch Lordotic TPLIF: 11mm x 28mm x 14mm x 6°; Spine Smith 0611-2815 Cynch Straight TPLIF: 11mm x 28mm x 15mm; Spine Smith 0611-2815-06 Cynch Lordotic TPLIF: 11mm x 28mm x 15mm x 6°; Spine Smith 0611-3307-06 Cynch Lordotic TPLIF: 11mm x 33mm x 7mm x 6°; Spine Smith 0611-3308 Cynch Straight TPLIF: 11mm x 33mm x 8mm; Spine Smith 0611-3308-06 Cynch Lordotic TPLIF: 11mm x 33mm x 8mm x 6°; Spine Smith 0611-3309 Cynch Straight TPLIF: 11mm x 33mm x 9mm; Spine Smith 0611-3309-06 Cynch Lordotic TPLIF: 11mm x 33mm x 9mm x 6°; Spine Smith 0611-3310 Cynch Straight TPLIF: 11mm x 33mm x 10mm; Spine Smith 0611-3310-06 Cynch Lordotic TPLIF: 11mm x 33mm x 10mm x 6°; Spine Smith 0611-3311 Cynch Straight TPLIF: 11mm x 33mm x 11mm; Spine Smith 0611-3311-06 Cynch Lordotic TPLIF: 11mm x 33mm x 11mm x 6°; Spine Smith 0611-3312 Cynch Straight TPLIF: 11mm x 33mm x 12mm; Spine Smith 0611-3312-06 Cynch Lordotic TPLIF: 11mm x 33mm x 12mm x 6°; Spine Smith 0611-3313 Cynch Straight TPLIF: 11mm x 33mm x 13mm; Spine Smith 0611-3313-06 Cynch Lordotic TPLIF: 11mm x 33mm x 13mm x 6°; Spine Smith 0611-3314 Cynch Straight TPLIF: 11mm x 33mm x 14mm; Spine Smith 0611-3314-06 Cynch Lordotic TPLIF: 11mm x 33mm x 14mm x 6°; Spine Smith 0611-3315 Cynch Straight TPLIF: 11mm x 33mm x 15mm; Spine Smith 0611-3315-06 Cynch Lordotic TPLIF: 11mm x 33mm x 15mm x 6°

Contract Manufacturer

BENVENUE MEDICAL, INC.

CA/USA

3007033608

2013

intervertebral fusion device with bone graft, lumbar - Benvenue IBF Implant System; Luna

U.S. Manufacturer of Export Only Devices

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Establishment Registration & Device Listing

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