The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Pca +15mm Modular Femoral Head.
| Device ID | K955305 |
| 510k Number | K955305 |
| Device Name: | PCA +15MM MODULAR FEMORAL HEAD |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Margaret F Crowe |
| Correspondent | Margaret F Crowe HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-20 |
| Decision Date | 1996-01-18 |