The following data is part of a premarket notification filed by Biomet Orthopedics, Inc. with the FDA for Rx 90 Femoral Stem And Rx 90 Lateralized Femoral Stem.
| Device ID | K023085 |
| 510k Number | K023085 |
| Device Name: | RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| 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 | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-17 |
| Decision Date | 2002-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304248175 | K023085 | 000 |
| 00880304208414 | K023085 | 000 |
| 00880304208421 | K023085 | 000 |
| 00880304248106 | K023085 | 000 |
| 00880304248113 | K023085 | 000 |
| 00880304248120 | K023085 | 000 |
| 00880304248137 | K023085 | 000 |
| 00880304248151 | K023085 | 000 |
| 00880304248168 | K023085 | 000 |
| 00880304208391 | K023085 | 000 |