The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Porous Coated Cruciate Retained Femoral Component.
| Device ID | K935726 |
| 510k Number | K935726 |
| Device Name: | EXACTECH POROUS COATED CRUCIATE RETAINED FEMORAL COMPONENT |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | EXACTECH, INC. 4613 N.W. 6TH STREET, SUITE D Gainesville, FL 32609 |
| Contact | Tim Seese |
| Correspondent | Tim Seese EXACTECH, INC. 4613 N.W. 6TH STREET, SUITE D Gainesville, FL 32609 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-01 |
| Decision Date | 1994-10-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862052728 | K935726 | 000 |
| 10885862052711 | K935726 | 000 |
| 10885862052704 | K935726 | 000 |
| 10885862052698 | K935726 | 000 |
| 10885862052681 | K935726 | 000 |