The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Duracon(tm) Unicompartmental Femoral Component.
| Device ID | K945613 |
| 510k Number | K945613 |
| Device Name: | DURACON(TM) UNICOMPARTMENTAL FEMORAL COMPONENT |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Margaret F Crowe |
| Correspondent | Margaret F Crowe HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | HSX |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-15 |
| Decision Date | 1995-03-06 |