The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Acetabular Dome Hole Plugs.
| Device ID | K942809 |
| 510k Number | K942809 |
| Device Name: | ACETABULAR DOME HOLE PLUGS |
| Classification | Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) |
| Applicant | OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Contact | Robert A Koch, J.d. |
| Correspondent | Robert A Koch, J.d. OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Product Code | JDL |
| CFR Regulation Number | 888.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-14 |
| Decision Date | 1994-09-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327037067 | K942809 | 000 |