510(k) K013629
- Device
- FINGER JOINT PROSTHESIS
- Applicant
- Avanta Orthopaedics, Inc.
- 510(k) number
- K013629
- Product code
- KYJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-01-25
- Date received
- 2001-11-05
- Regulation
- 888.3230
- Classification name
- Prosthesis, Finger, Constrained, Polymer
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- LOUISE M FOCHT
- Address
- 9369 Carroll Park Dr., Suite A San Diego CA US 92121 92121
FDA Registration Numbers#
- 1818910
- 1649379
- 3003477135
- 3002807310
- 2031009
- 1834331
- 3014596751
- 3008395366
- 2183946
- 1226544
- 3002894438
- 1221934
- 3010372554
- 3024706750
- 3007366790
- 3014207283
- 1000286794
- 3008868758
- 3015239144
- 3016669046
Source Documents#
Other 510(k) Records For Product Code KYJ#
| 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 |
| 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 |