KYJ — Prosthesis, Finger, Constrained, Polymer Class II
FDA Device Classification
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 |