The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Pca Acetabular Insert Ii.
| Device ID | K921384 |
| 510k Number | K921384 |
| Device Name: | PCA ACETABULAR INSERT II |
| Classification | Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) |
| Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Denise E Murphy |
| Correspondent | Denise E Murphy HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | JDL |
| CFR Regulation Number | 888.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-23 |
| Decision Date | 1992-06-25 |