Ascension Silicone MCP; Ascension Silicone PIP
FDA 510(k) clearance K233670 · decided 2023-12-14
Clearance details
- K-number
- K233670
- Device name
- Ascension Silicone MCP; Ascension Silicone PIP
- Applicant
- Ascension Orthopedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-11-15
- Decision date
- 2023-12-14
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- KYJ
- Device class
- 2
- Regulation number
- 888.3230
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BRM Digitalis Spacer (K220142) | Brm Extremities Srl | 2023-04-04 |
| KeriFlex® MCP and PIP Finger Joint Prostheses (K211385) | Keri Medical SA | 2022-07-27 |
| OSTEOTEC SILICONE FINGER IMPLANT (K140453) | Osteotec, Ltd. | 2015-04-17 |
| MODIFICATION TO DEPUY NEUFLEX PIP FINGER (K083107) | DePuy Orthopaedics, Inc. | 2009-02-09 |
| ASCENSION SILICONE PIP (K082231) | Ascension Orthopedics, Inc. | 2009-01-12 |
| ASCENSION SILLICONE MCP (K022892) | Ascension Orthopedics, Inc. | 2002-11-25 |
| FINGER JOINT PROSTHESIS (K013629) | Avanta Orthopaedics, Inc. | 2002-01-25 |
| DEPUY NEUFLEX PIP FINGER (K001922) | Depuy, Inc. | 2000-08-29 |
| DEPUY DUPONT ORTHOPAEDICS FINGER JOINT PROSTHESIS (K970544) | Depuy, Inc. | 1997-09-12 |
| SUTTER PROXIMAL INTERPHALANGEAL JOINT (K931588) | Sutter Corp. | 1994-03-10 |
| SUTTER FINGER JOINT PROSTHESIS (K870200) | Sutter Biomedical, Inc. | 1987-10-09 |
| MARNE M.T.P.J. ORTHOPEDIC IMPLANT (K781380) | Farah , Ltd. | 1979-02-21 |
Recalls involving this device
No recalls on record reference this clearance.