The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Modular Calcar Replacement.
| Device ID | K913649 |
| 510k Number | K913649 |
| Device Name: | MODULAR CALCAR REPLACEMENT |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Carol Vierling |
| Correspondent | Carol Vierling ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-16 |
| Decision Date | 1991-11-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024140127 | K913649 | 000 |
| 00889024139978 | K913649 | 000 |
| 00889024139985 | K913649 | 000 |
| 00889024139992 | K913649 | 000 |
| 00889024140004 | K913649 | 000 |
| 00889024140011 | K913649 | 000 |
| 00889024140028 | K913649 | 000 |
| 00889024140035 | K913649 | 000 |
| 00889024140042 | K913649 | 000 |
| 00889024140059 | K913649 | 000 |
| 00889024140066 | K913649 | 000 |
| 00889024140073 | K913649 | 000 |
| 00889024140080 | K913649 | 000 |
| 00889024140097 | K913649 | 000 |
| 00889024140103 | K913649 | 000 |
| 00889024140110 | K913649 | 000 |
| 00889024139961 | K913649 | 000 |