The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Segmental System Proximal Femoral Component And Small Diameter Stem Extensions.
| Device ID | K101296 |
| 510k Number | K101296 |
| Device Name: | ZIMMER SEGMENTAL SYSTEM PROXIMAL FEMORAL COMPONENT AND SMALL DIAMETER STEM EXTENSIONS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Christina Forney |
| Correspondent | Christina Forney ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | LZO |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KRO |
| Subsequent Product Code | KWL |
| Subsequent Product Code | KWY |
| Subsequent Product Code | KWZ |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LWJ |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-10 |
| Decision Date | 2010-07-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024196773 | K101296 | 000 |
| 00889024198838 | K101296 | 000 |
| 00889024198821 | K101296 | 000 |
| 00889024198807 | K101296 | 000 |
| 00889024198531 | K101296 | 000 |
| 00889024198524 | K101296 | 000 |
| 00889024198517 | K101296 | 000 |
| 00889024198401 | K101296 | 000 |
| 00889024198395 | K101296 | 000 |
| 00889024197541 | K101296 | 000 |
| 00889024197435 | K101296 | 000 |
| 00889024197428 | K101296 | 000 |
| 00889024197411 | K101296 | 000 |
| 00889024198845 | K101296 | 000 |
| 00889024197701 | K101296 | 000 |
| 00889024195806 | K101296 | 000 |
| 00889024198135 | K101296 | 000 |
| 00889024198128 | K101296 | 000 |
| 00889024198111 | K101296 | 000 |
| 00889024198029 | K101296 | 000 |
| 00889024198012 | K101296 | 000 |
| 00889024198005 | K101296 | 000 |
| 00889024197831 | K101296 | 000 |
| 00889024197824 | K101296 | 000 |
| 00889024197817 | K101296 | 000 |
| 00889024197725 | K101296 | 000 |
| 00889024197718 | K101296 | 000 |
| 00889024197282 | K101296 | 000 |