|
Device |
staple, fixation, bone |
Product Code | JDR |
Regulation Number |
888.3030
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ARTHREX INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
AUSTIN & ASSOCIATES, INC./TELOS MEDICAL EQUIPMENT |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOMEDICAL ENT., INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
BIOMEDICAL ENTERPRISES, INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BIOMEDICAL ENTERPRISES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BIOMET MANUFACTURING CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
CROSSROADS EXTEMITY SYSTEMS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CROSSROADS EXTREMITY SYSTEMS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DALLEN MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
EPIC EXTREMELY, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EXOTOE LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
F & A FOUNDATION LLC D.B.A. REIGN MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FIRST RAY LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
FUSION ORTHOPEDICS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GRAMERCY EXTREMITY ORTHOPEDICS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IN2BONES SAS |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
IN2BONESUSA, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INSTRATEK, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDACTA INTERNATIONAL SA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDARTIS AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDARTIS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDISCOPE MANUFACTURING, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDLINE INDUSTRIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDLINE INDUSTRIES, LP |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDSHAPE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MERETE MEDICAL GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
METASURG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
METRIC MEDICAL DEVICES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MX ORTHOPEDICS, CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NEOSTEO |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEXTREMITY SOLUTIONS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEXTREMITY SOLUTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NOVASTEP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NOVATSEP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NVISION BIOMEDICAL TECHNOLOGIES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHO SOLUTIONS UK LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHODISCOVERY GROUP LLC(D.B.A. CROSSROADS EXTREMITY SYSTEMS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOHELIX SURGICAL DESIGNS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ORTHOVESTMENTS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OT MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PARAGON 28 |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PARAGON 28 INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PARAGON 28, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RESTOR3D |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RESTORE SURGICAL LLC DBA INSTRATEK |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RMR ORTHO, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOLANA SURGICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SUSPENSION ORTHOPAEDIC SOLUTIONS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYNTHES (USA) PRODUCTS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TREACE MEDICAL CONCEPTS |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
TRILLIANT SURGICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRILLIANT SURGICAL LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRIMED, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TYBER MEDICAL, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VILEX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VILEX, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WRIGHT MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|