The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Gamma3 Nail System.
Device ID | K043431 |
510k Number | K043431 |
Device Name: | GAMMA3 NAIL SYSTEM |
Classification | Rod, Fixation, Intramedullary And Accessories |
Applicant | HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430 |
Contact | Jennifer Kosoy |
Correspondent | Jennifer Kosoy HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430 |
Product Code | HSB |
CFR Regulation Number | 888.3020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-12-13 |
Decision Date | 2005-02-16 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07613252162919 | K043431 | 000 |
04546540595942 | K043431 | 000 |
04546540595959 | K043431 | 000 |
04546540595966 | K043431 | 000 |
04546540595973 | K043431 | 000 |
04546540595980 | K043431 | 000 |
04546540595997 | K043431 | 000 |
04546540596000 | K043431 | 000 |
04546540596017 | K043431 | 000 |
04546540596024 | K043431 | 000 |
04546540596031 | K043431 | 000 |
07613252162896 | K043431 | 000 |
07613252162902 | K043431 | 000 |
04546540504432 | K043431 | 000 |