The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Taperloc Femoral Stem And Universal Acetabular Com.
Device ID | K921301 |
510k Number | K921301 |
Device Name: | TAPERLOC FEMORAL STEM AND UNIVERSAL ACETABULAR COM |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
Applicant | BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw, IN 46581 -0587 |
Contact | Patricia S Beres |
Correspondent | Patricia S Beres BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw, IN 46581 -0587 |
Product Code | LPH |
CFR Regulation Number | 888.3358 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-03-18 |
Decision Date | 1994-02-16 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00880304553927 | K921301 | 000 |
00880304553910 | K921301 | 000 |