The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Mayo Conservative Hip Prosthesis, Model 8026 Series.
Device ID | K030733 |
510k Number | K030733 |
Device Name: | MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 8026 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 | 2003-03-10 |
Decision Date | 2003-05-01 |
Summary: | summary |