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 |