The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Rejuvenate Monolithic Size 4 Hip Stem.
| Device ID | K091161 |
| 510k Number | K091161 |
| Device Name: | REJUVENATE MONOLITHIC SIZE 4 HIP STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | Estela Celi |
| Correspondent | Estela Celi HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | MEH |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWY |
| Subsequent Product Code | KWZ |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-21 |
| Decision Date | 2009-06-16 |
| Summary: | summary |