The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Hoffmann Light System.
| Device ID | K073076 |
| 510k Number | K073076 |
| Device Name: | HOFFMANN LIGHT SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Francisco Haro |
| Correspondent | Francisco Haro HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-31 |
| Decision Date | 2008-02-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613154919338 | K073076 | 000 |
| 07613154691319 | K073076 | 000 |
| 07613154691302 | K073076 | 000 |
| 07613154691296 | K073076 | 000 |
| 07613154691289 | K073076 | 000 |
| 07613154691272 | K073076 | 000 |
| 07613154691265 | K073076 | 000 |
| 07613154691258 | K073076 | 000 |
| 07613154691241 | K073076 | 000 |