The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Enhanced Modular Austin Moore Hip.
Device ID | K936044 |
510k Number | K936044 |
Device Name: | ENHANCED MODULAR AUSTIN MOORE HIP |
Classification | Prosthesis, Hip, Semi-constrained, Composite/metal |
Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
Contact | Max Sherman |
Correspondent | Max Sherman ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
Product Code | KMC |
CFR Regulation Number | 888.3340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-12-20 |
Decision Date | 1994-04-26 |