The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Heritage Hip System.
| Device ID | K963109 |
| 510k Number | K963109 |
| Device Name: | HERITAGE HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Lynnette Whitaker |
| Correspondent | Lynnette Whitaker 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 | 1996-08-12 |
| Decision Date | 1997-01-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024138544 | K963109 | 000 |
| 00889024138438 | K963109 | 000 |
| 00889024138445 | K963109 | 000 |
| 00889024138452 | K963109 | 000 |
| 00889024138469 | K963109 | 000 |
| 00889024138476 | K963109 | 000 |
| 00889024138483 | K963109 | 000 |
| 00889024138490 | K963109 | 000 |
| 00889024138506 | K963109 | 000 |
| 00889024138513 | K963109 | 000 |
| 00889024138520 | K963109 | 000 |
| 00889024138537 | K963109 | 000 |
| 00889024138421 | K963109 | 000 |