The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Hap Bio-groove Total Hip Prosth (bio-interfaces).
| Device ID | K912370 |
| 510k Number | K912370 |
| Device Name: | HAP BIO-GROOVE TOTAL HIP PROSTH (BIO-INTERFACES) |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw, IN 46581 -0587 |
| Contact | Patricia M Sandborn |
| Correspondent | Patricia M Sandborn BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw, IN 46581 -0587 |
| Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-29 |
| Decision Date | 1991-10-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304069060 | K912370 | 000 |
| 00880304069053 | K912370 | 000 |