The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Hoffmann Ii Micro External Fixation System.
| Device ID | K042019 |
| 510k Number | K042019 |
| Device Name: | HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Vivian Kelly |
| Correspondent | Vivian Kelly 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 | 2004-07-27 |
| Decision Date | 2004-09-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327091540 | K042019 | 000 |
| 07613327091533 | K042019 | 000 |
| 07613327089165 | K042019 | 000 |
| 07613327088342 | K042019 | 000 |
| 07613327072853 | K042019 | 000 |
| 04546540390011 | K042019 | 000 |
| 04546540390004 | K042019 | 000 |
| 04546540389992 | K042019 | 000 |
| 04546540389985 | K042019 | 000 |