The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Osteo Ic Femoral And Tibial Nails In Titanium Alloy.
| Device ID | K992063 |
| 510k Number | K992063 |
| Device Name: | OSTEO IC FEMORAL AND TIBIAL NAILS IN TITANIUM ALLOY |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Marybeth Naughton |
| Correspondent | Marybeth Naughton HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-18 |
| Decision Date | 1999-09-03 |
| Summary: | summary |