The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Pca 36mm Femoral Heads.
| Device ID | K061168 |
| 510k Number | K061168 |
| Device Name: | PCA 36MM FEMORAL HEADS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | Francisco Haro |
| Correspondent | Francisco Haro HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-27 |
| Decision Date | 2006-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327138634 | K061168 | 000 |
| 07613327138580 | K061168 | 000 |
| 07613327138535 | K061168 | 000 |
| 07613327138511 | K061168 | 000 |
| 07613327138276 | K061168 | 000 |