The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Osteonics Universal Distal Cement Plug.
| Device ID | K992462 |
| 510k Number | K992462 |
| Device Name: | OSTEONICS UNIVERSAL DISTAL CEMENT PLUG |
| Classification | Cement Obturator |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Kate Sutton |
| Correspondent | Kate Sutton HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | LZN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-23 |
| Decision Date | 1999-08-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327013887 | K992462 | 000 |