The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for 150mm Cocr Bimetric Head/neck Replacement Hip Stem- Color Buff Finish.
Device ID | K983710 |
510k Number | K983710 |
Device Name: | 150MM COCR BIMETRIC HEAD/NECK REPLACEMENT HIP STEM- COLOR BUFF FINISH |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
Contact | Fred Mcclure |
Correspondent | Fred Mcclure BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
Product Code | JDI |
CFR Regulation Number | 888.3350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-10-21 |
Decision Date | 1998-12-02 |
Summary: | summary |