The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for T2 Recon Nail System.
Device ID | K051624 |
510k Number | K051624 |
Device Name: | T2 RECON NAIL SYSTEM |
Classification | Rod, Fixation, Intramedullary And Accessories |
Applicant | HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
Contact | Vivian Kelly |
Correspondent | Vivian Kelly HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
Product Code | HSB |
CFR Regulation Number | 888.3020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-06-20 |
Decision Date | 2005-07-07 |
Summary: | summary |