The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Universal Taper Delta Femoral Head.
| Device ID | K070885 |
| 510k Number | K070885 |
| Device Name: | UNIVERSAL TAPER DELTA FEMORAL HEAD |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | Tiffani Rogers |
| Correspondent | Tiffani Rogers HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-30 |
| Decision Date | 2007-05-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546540608451 | K070885 | 000 |
| 04546540608321 | K070885 | 000 |
| 04546540608338 | K070885 | 000 |
| 04546540608345 | K070885 | 000 |
| 04546540608383 | K070885 | 000 |
| 04546540608390 | K070885 | 000 |
| 04546540608406 | K070885 | 000 |
| 04546540608413 | K070885 | 000 |
| 04546540608420 | K070885 | 000 |
| 04546540608437 | K070885 | 000 |
| 04546540608444 | K070885 | 000 |
| 04546540608314 | K070885 | 000 |