The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Versys Hip System Beaded Hip Prosthesis.
| Device ID | K973714 |
| 510k Number | K973714 |
| Device Name: | VERSYS HIP SYSTEM BEADED HIP PROSTHESIS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | ZIMMER, INC. 508 & 727 NORTH DETROIT ST. Warsaw, IN 46580 |
| Contact | Karen Cain |
| Correspondent | Karen Cain ZIMMER, INC. 508 & 727 NORTH DETROIT ST. Warsaw, IN 46580 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-29 |
| Decision Date | 1997-12-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024137301 | K973714 | 000 |
| 00889024136991 | K973714 | 000 |
| 00889024136977 | K973714 | 000 |
| 00889024136922 | K973714 | 000 |
| 00889024136847 | K973714 | 000 |
| 00889024136748 | K973714 | 000 |
| 00889024136595 | K973714 | 000 |
| 00889024136571 | K973714 | 000 |
| 00889024136526 | K973714 | 000 |
| 00889024136502 | K973714 | 000 |
| 00889024136458 | K973714 | 000 |
| 00889024137004 | K973714 | 000 |
| 00889024137059 | K973714 | 000 |
| 00889024137295 | K973714 | 000 |
| 00889024137271 | K973714 | 000 |
| 00889024137226 | K973714 | 000 |
| 00889024137219 | K973714 | 000 |
| 00889024137196 | K973714 | 000 |
| 00889024137165 | K973714 | 000 |
| 00889024137158 | K973714 | 000 |
| 00889024137134 | K973714 | 000 |
| 00889024137080 | K973714 | 000 |
| 00889024137073 | K973714 | 000 |
| 00889024136434 | K973714 | 000 |