The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Segmental System Variable Stiffness Stem Extensions And Intercalary Segments.
| Device ID | K081860 |
| 510k Number | K081860 |
| Device Name: | ZIMMER SEGMENTAL SYSTEM VARIABLE STIFFNESS STEM EXTENSIONS AND INTERCALARY SEGMENTS |
| 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 | Toni Kingsley |
| Correspondent | Toni Kingsley ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-01 |
| Decision Date | 2008-09-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024195981 | K081860 | 000 |
| 00889024198043 | K081860 | 000 |
| 00889024198050 | K081860 | 000 |
| 00889024198067 | K081860 | 000 |
| 00889024198074 | K081860 | 000 |
| 00889024198081 | K081860 | 000 |
| 00889024198098 | K081860 | 000 |
| 00889024198104 | K081860 | 000 |
| 00889024198142 | K081860 | 000 |
| 00889024198159 | K081860 | 000 |
| 00889024198166 | K081860 | 000 |
| 00889024198173 | K081860 | 000 |
| 00889024198180 | K081860 | 000 |
| 00889024198197 | K081860 | 000 |
| 00889024198203 | K081860 | 000 |
| 00889024198210 | K081860 | 000 |
| 00889024195967 | K081860 | 000 |
| 00889024195974 | K081860 | 000 |
| 00889024198036 | K081860 | 000 |