The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Howmedica Vitalock 22mm Acertabular Shell And System 12 Inserts.
| Device ID | K951115 |
| 510k Number | K951115 |
| Device Name: | HOWMEDICA VITALOCK 22MM ACERTABULAR SHELL AND SYSTEM 12 INSERTS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Mary C Spicer |
| Correspondent | Mary C Spicer HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-10 |
| Decision Date | 1995-06-16 |