The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Collarless Polished Taper Hip Prosthesis.
Device ID | K960658 |
510k Number | K960658 |
Device Name: | COLLARLESS POLISHED TAPER HIP PROSTHESIS |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
Contact | Ruth Ann Wood |
Correspondent | Ruth Ann Wood 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 | 1996-02-16 |
Decision Date | 1996-07-16 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00889024145931 | K960658 | 000 |
00889024145818 | K960658 | 000 |
00889024145801 | K960658 | 000 |
00889024145795 | K960658 | 000 |
00889024145788 | K960658 | 000 |
00889024145771 | K960658 | 000 |
00889024145764 | K960658 | 000 |
00889024145757 | K960658 | 000 |
00889024145740 | K960658 | 000 |
00889024145825 | K960658 | 000 |
00889024145832 | K960658 | 000 |
00889024145849 | K960658 | 000 |
00889024145924 | K960658 | 000 |
00889024145917 | K960658 | 000 |
00889024145900 | K960658 | 000 |
00889024145894 | K960658 | 000 |
00889024145887 | K960658 | 000 |
00889024145870 | K960658 | 000 |
00889024145863 | K960658 | 000 |
00889024145856 | K960658 | 000 |
00889024145733 | K960658 | 000 |