The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Modification To T2 Recon Nail System.
Device ID | K083437 |
510k Number | K083437 |
Device Name: | MODIFICATION TO T2 RECON NAIL SYSTEM |
Classification | Rod, Fixation, Intramedullary And Accessories |
Applicant | HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430 |
Contact | Avital Merl-margulies |
Correspondent | Avital Merl-margulies HOWMEDICA OSTEONICS CORP. 325 Corporate Drive 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 | 2008-11-20 |
Decision Date | 2008-12-18 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07613154863242 | K083437 | 000 |