The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Walker Hip Prosthesis.
Device ID | K915222 |
510k Number | K915222 |
Device Name: | WALKER HIP PROSTHESIS |
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 | Carol Vierling |
Correspondent | Carol Vierling ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
Product Code | LZO |
CFR Regulation Number | 888.3353 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-11-20 |
Decision Date | 1993-06-22 |