The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Reach Femoral Component.
| Device ID | K000760 |
| 510k Number | K000760 |
| Device Name: | REACH FEMORAL 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 | Michelle L Mckinley |
| Correspondent | Michelle L Mckinley 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 | 2000-03-08 |
| Decision Date | 2000-05-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304200722 | K000760 | 000 |
| 00880304011120 | K000760 | 000 |