The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Uhmwp Acetabular Component.
| Device ID | K912426 |
| 510k Number | K912426 |
| Device Name: | UHMWP ACETABULAR COMPONENT |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| 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 | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-31 |
| Decision Date | 1991-08-21 |