Product code KYJ
- Device name
- Prosthesis, Finger, Constrained, Polymer
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3230
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233670 | Ascension Silicone MCP; Ascension Silicone PIP | Ascension Orthopedics, Inc. | 2023-12-14 |
| K220142 | BRM Digitalis Spacer | Brm Extremities Srl | 2023-04-04 |
| K211385 | KeriFlex® MCP and PIP Finger Joint Prostheses | Keri Medical SA | 2022-07-27 |
| K140453 | OSTEOTEC SILICONE FINGER IMPLANT | Osteotec, Ltd. | 2015-04-17 |
| K083107 | MODIFICATION TO DEPUY NEUFLEX PIP FINGER | DePuy Orthopaedics, Inc. | 2009-02-09 |
| K082231 | ASCENSION SILICONE PIP | Ascension Orthopedics, Inc. | 2009-01-12 |
| K022892 | ASCENSION SILLICONE MCP | Ascension Orthopedics, Inc. | 2002-11-25 |
| K013629 | FINGER JOINT PROSTHESIS | Avanta Orthopaedics, Inc. | 2002-01-25 |
| K001922 | DEPUY NEUFLEX PIP FINGER | Depuy, Inc. | 2000-08-29 |
| K970544 | DEPUY DUPONT ORTHOPAEDICS FINGER JOINT PROSTHESIS | Depuy, Inc. | 1997-09-12 |
| K931588 | SUTTER PROXIMAL INTERPHALANGEAL JOINT | Sutter Corp. | 1994-03-10 |
| K870200 | SUTTER FINGER JOINT PROSTHESIS | Sutter Biomedical, Inc. | 1987-10-09 |
| K781380 | MARNE M.T.P.J. ORTHOPEDIC IMPLANT | Farah , Ltd. | 1979-02-21 |
| K781668 | GAMMA RADIATION STERILIZATION PRECEDURE | Cutter Laboratories, Inc. | 1978-11-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10381780235125 | Integra® | Ascension Orthopedics, Inc. | 2017-10-03 |
| 10381780236153 | Integra® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236658 | Integra® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236641 | Ascension® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236634 | Ascension® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236627 | Ascension® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236610 | Ascension® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236603 | Ascension® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236597 | Ascension® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236221 | Integra® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236214 | Integra® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236207 | Integra® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236191 | Integra® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236184 | Integra® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236177 | Integra® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236160 | Integra® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780235057 | Ascension® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236146 | Ascension® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236139 | Ascension® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236122 | Ascension® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236115 | Ascension® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236108 | Ascension® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236092 | Ascension® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236085 | Ascension® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236078 | Ascension® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236061 | Ascension® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236054 | Ascension® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236047 | Ascension® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236030 | Ascension® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780235064 | Integra® | Ascension Orthopedics, Inc. | 2016-08-15 |