The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for P.c.a. Hip System.
| Device ID | K831373 |
| 510k Number | K831373 |
| Device Name: | P.C.A. HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | HOWMEDICA CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-27 |
| Decision Date | 1983-08-26 |