The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for P.c.a. Universal Acetabular Component System.
| Device ID | K853886 |
| 510k Number | K853886 |
| Device Name: | P.C.A. UNIVERSAL ACETABULAR COMPONENT SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Robert E Smith |
| Correspondent | Robert E Smith HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-19 |
| Decision Date | 1985-11-25 |