Panels › Orthopedic › Product code KYJ · Class 2
Prosthesis, Finger, Constrained, Polymer
Regulation 888.3230
0510(k)s in 12 months (14 all time)
0recalls in 12 months (4 all time)
2recalls that name a 510(k)
Top companies in KYJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Ascension Orthopedics, Inc. | 3 | 0 |
| Depuy, Inc. | 2 | 0 |
| Osteotec, Ltd. | 1 | 1 |
| Wright Medical Technology, Inc. | 0 | 2 |
| Avanta Orthopaedics, Inc. | 1 | 0 |
| Brm Extremities Srl | 1 | 0 |
| Cutter Laboratories, Inc. | 1 | 0 |
| DePuy Orthopaedics, Inc. | 1 | 0 |
| Farah , Ltd. | 1 | 0 |
| Integra Lifesciences Sales Llc | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 14, 2023 | K233670 | Ascension Silicone MCP; Ascension Silicone PIP Ascension Orthopedics, Inc. | KYJ |
| Apr 4, 2023 | K220142 | BRM Digitalis Spacer Brm Extremities Srl, IT | KYJ |
| Jul 27, 2022 | K211385 | KeriFlex® MCP and PIP Finger Joint Prostheses Keri Medical SA, CH | KYJ |
| Apr 17, 2015 | K140453 | OSTEOTEC SILICONE FINGER IMPLANT Osteotec, Ltd., GB | KYJ |
| Feb 9, 2009 | K083107 | MODIFICATION TO DEPUY NEUFLEX PIP FINGER DePuy Orthopaedics, Inc. | KYJ |
| Jan 12, 2009 | K082231 | ASCENSION SILICONE PIP Ascension Orthopedics, Inc. | KYJ |
| Nov 25, 2002 | K022892 | ASCENSION SILLICONE MCP Ascension Orthopedics, Inc. | KYJ |
| Jan 25, 2002 | K013629 | FINGER JOINT PROSTHESIS Avanta Orthopaedics, Inc. | KYJ |
| Aug 29, 2000 | K001922 | DEPUY NEUFLEX PIP FINGER Depuy, Inc. | KYJ |
| Sep 12, 1997 | K970544 | DEPUY DUPONT ORTHOPAEDICS FINGER JOINT PROSTHESIS Depuy, Inc. | KYJ |
| Mar 10, 1994 | K931588 | SUTTER PROXIMAL INTERPHALANGEAL JOINT Sutter Corp. | KYJ |
| Oct 9, 1987 | K870200 | SUTTER FINGER JOINT PROSTHESIS Sutter Biomedical, Inc. | KYJ |
| Feb 21, 1979 | K781380 | MARNE M.T.P.J. ORTHOPEDIC IMPLANT Farah , Ltd. | KYJ |
| Nov 3, 1978 | K781668 | GAMMA RADIATION STERILIZATION PRECEDURE Cutter Laboratories, Inc. | KYJ |
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