The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Lfic Or Fetto Hip.
Device ID | K952776 |
510k Number | K952776 |
Device Name: | LFIC OR FETTO HIP |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented |
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 | LWJ |
CFR Regulation Number | 888.3360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-06-16 |
Decision Date | 1996-02-14 |