The following data is part of a premarket notification filed by Biomet Orthopedics, Inc. with the FDA for Ha Modular Reach Proximal Porous And Ha Modular Reach Collared Proximal Porous Femoral Stems.
| Device ID | K022463 |
| 510k Number | K022463 |
| Device Name: | HA MODULAR REACH PROXIMAL POROUS AND HA MODULAR REACH COLLARED PROXIMAL POROUS FEMORAL STEMS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | BIOMET ORTHOPEDICS, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Dalene T Binkley |
| Correspondent | Dalene T Binkley BIOMET ORTHOPEDICS, INC. 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 | 2002-07-26 |
| Decision Date | 2002-08-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304839342 | K022463 | 000 |
| 00880304282117 | K022463 | 000 |
| 00880304282100 | K022463 | 000 |
| 00880304282094 | K022463 | 000 |
| 00880304282087 | K022463 | 000 |
| 00880304282070 | K022463 | 000 |
| 00880304009035 | K022463 | 000 |
| 00880304007673 | K022463 | 000 |
| 00880304005662 | K022463 | 000 |
| 00880304282124 | K022463 | 000 |
| 00880304839250 | K022463 | 000 |
| 00880304839335 | K022463 | 000 |
| 00880304839328 | K022463 | 000 |
| 00880304839311 | K022463 | 000 |
| 00880304839304 | K022463 | 000 |
| 00880304839298 | K022463 | 000 |
| 00880304839281 | K022463 | 000 |
| 00880304839274 | K022463 | 000 |
| 00880304839267 | K022463 | 000 |
| 00880304003293 | K022463 | 000 |