The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Reach Hip Component.
| Device ID | K982367 |
| 510k Number | K982367 |
| Device Name: | REACH HIP COMPONENT |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Julie K Ryan |
| Correspondent | Julie K Ryan BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 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 | 1998-07-07 |
| Decision Date | 1998-08-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304839144 | K982367 | 000 |
| 00880304839137 | K982367 | 000 |
| 00880304839120 | K982367 | 000 |
| 00880304839113 | K982367 | 000 |
| 00880304222632 | K982367 | 000 |
| 00880304222625 | K982367 | 000 |
| 00880304222618 | K982367 | 000 |
| 00880304222601 | K982367 | 000 |