The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Modification To Hoffmann Ii Micro External Fixation System.
| Device ID | K052037 |
| 510k Number | K052037 |
| Device Name: | MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | Vivian Kelly |
| Correspondent | Vivian Kelly HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-28 |
| Decision Date | 2005-08-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613154206841 | K052037 | 000 |
| 04546540492838 | K052037 | 000 |
| 04546540492807 | K052037 | 000 |
| 04546540492791 | K052037 | 000 |