KYJ — Prosthesis, Finger, Constrained, Polymer Class II
FDA product code KYJ covers "Prosthesis, Finger, Constrained, Polymer", a Class II medical device regulated under 21 CFR 888.3230. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 14 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KYJ
- Device Class
- Class II
- Regulation Number
- 888.3230
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K233670 | ascension orthopedics | Ascension Silicone MCP; Ascension Silicone PIP | December 14, 2023 |
| K220142 | brm extremities | BRM Digitalis Spacer | April 4, 2023 |
| K211385 | keri medical | KeriFlex® MCP and PIP Finger Joint Prostheses | July 27, 2022 |
| K140453 | osteotec | OSTEOTEC SILICONE FINGER IMPLANT | April 17, 2015 |
| K083107 | depuy orthopaedics | MODIFICATION TO DEPUY NEUFLEX PIP FINGER | February 9, 2009 |
| K082231 | ascension orthopedics | ASCENSION SILICONE PIP | January 12, 2009 |
| K022892 | ascension orthopedics | ASCENSION SILLICONE MCP | November 25, 2002 |
| K013629 | avanta orthopaedics | FINGER JOINT PROSTHESIS | January 25, 2002 |
| K001922 | depuy | DEPUY NEUFLEX PIP FINGER | August 29, 2000 |
| K970544 | depuy | DEPUY DUPONT ORTHOPAEDICS FINGER JOINT PROSTHESIS | September 12, 1997 |
| K931588 | sutter | SUTTER PROXIMAL INTERPHALANGEAL JOINT | March 10, 1994 |
| K870200 | sutter biomedical | SUTTER FINGER JOINT PROSTHESIS | October 9, 1987 |
| K781380 | farah | MARNE M.T.P.J. ORTHOPEDIC IMPLANT | February 21, 1979 |
| K781668 | cutter laboratories | GAMMA RADIATION STERILIZATION PRECEDURE | November 3, 1978 |