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 |