The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Modular Reach Hip.
| Device ID | K994038 |
| 510k Number | K994038 |
| Device Name: | MODULAR REACH HIP |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| 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 | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-29 |
| Decision Date | 1999-12-22 |
| Summary: | summary |