FDA Product Code
FDA Product Code KYJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3230
510(k) Clearances — 14 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K233670 | Ascension Silicone MCP; Ascension Silicone PIP | Ascension Orthopedics, Inc. | 2023-12-14 | Special | PDF ↗ |
| K220142 | BRM Digitalis Spacer | Brm Extremities Srl | 2023-04-04 | Traditional | PDF ↗ |
| K211385 | KeriFlex® MCP and PIP Finger Joint Prostheses | Keri Medical SA | 2022-07-27 | Traditional | PDF ↗ |
| K140453 | OSTEOTEC SILICONE FINGER IMPLANT | Osteotec, Ltd. | 2015-04-17 | Traditional | PDF ↗ |
| K083107 | MODIFICATION TO DEPUY NEUFLEX PIP FINGER | DePuy Orthopaedics, Inc. | 2009-02-09 | Traditional | PDF ↗ |
| K082231 | ASCENSION SILICONE PIP | Ascension Orthopedics, Inc. | 2009-01-12 | Traditional | PDF ↗ |
| K022892 | ASCENSION SILLICONE MCP | Ascension Orthopedics, Inc. | 2002-11-25 | Traditional | PDF ↗ |
| K013629 | FINGER JOINT PROSTHESIS | Avanta Orthopaedics, Inc. | 2002-01-25 | Traditional | PDF ↗ |
| K001922 | DEPUY NEUFLEX PIP FINGER | Depuy, Inc. | 2000-08-29 | Traditional | PDF ↗ |
| K970544 | DEPUY DUPONT ORTHOPAEDICS FINGER JOINT PROSTHESIS | Depuy, Inc. | 1997-09-12 | Traditional | PDF ↗ |
| K931588 | SUTTER PROXIMAL INTERPHALANGEAL JOINT | Sutter Corp. | 1994-03-10 | Traditional | PDF ↗ |
| K870200 | SUTTER FINGER JOINT PROSTHESIS | Sutter Biomedical, Inc. | 1987-10-09 | Traditional | PDF ↗ |
| K781380 | MARNE M.T.P.J. ORTHOPEDIC IMPLANT | Farah , Ltd. | 1979-02-21 | Traditional | PDF ↗ |
| K781668 | GAMMA RADIATION STERILIZATION PRECEDURE | Cutter Laboratories, Inc. | 1978-11-03 | Traditional | PDF ↗ |
Product code KYJ · Class II · Orthopedic. Data: openFDA.