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 |