The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics Polyethylene Acetabular Components.
| Device ID | K974685 |
| 510k Number | K974685 |
| Device Name: | OSTEONICS POLYETHYLENE ACETABULAR COMPONENTS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Contact | Donna S Wilson |
| Correspondent | Donna S Wilson OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Product Code | JDI |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LWJ |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-16 |
| Decision Date | 1998-09-22 |
| Summary: | summary |