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 |