The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Anatomic Ii Hip Prosthesis.
| Device ID | K041109 |
| 510k Number | K041109 |
| Device Name: | ZIMMER ANATOMIC II HIP PROSTHESIS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Dalene T Binkley |
| Correspondent | Dalene T Binkley ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-28 |
| Decision Date | 2004-07-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024127968 | K041109 | 000 |
| 00889024127838 | K041109 | 000 |
| 00889024127821 | K041109 | 000 |
| 00889024127814 | K041109 | 000 |
| 00889024127807 | K041109 | 000 |
| 00889024127791 | K041109 | 000 |
| 00889024127784 | K041109 | 000 |
| 00889024127777 | K041109 | 000 |
| 00889024127760 | K041109 | 000 |
| 00889024127753 | K041109 | 000 |
| 00889024127746 | K041109 | 000 |
| 00889024127845 | K041109 | 000 |
| 00889024127852 | K041109 | 000 |
| 00889024127951 | K041109 | 000 |
| 00889024127944 | K041109 | 000 |
| 00889024127937 | K041109 | 000 |
| 00889024127920 | K041109 | 000 |
| 00889024127913 | K041109 | 000 |
| 00889024127906 | K041109 | 000 |
| 00889024127890 | K041109 | 000 |
| 00889024127883 | K041109 | 000 |
| 00889024127876 | K041109 | 000 |
| 00889024127869 | K041109 | 000 |
| 00889024127739 | K041109 | 000 |