The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer M/l Taper Hip Prosthesis, 7711 Series.
Device ID | K032726 |
510k Number | K032726 |
Device Name: | ZIMMER M/L TAPER HIP PROSTHESIS, 7711 SERIES |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
Contact | Laura D Williams |
Correspondent | Laura D Williams ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
Product Code | LPH |
CFR Regulation Number | 888.3358 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-09-03 |
Decision Date | 2003-10-22 |
Summary: | summary |