The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Hoffmann Ii Compact Mri External Fixation System.
| Device ID | K053038 |
| 510k Number | K053038 |
| Device Name: | HOFFMANN II COMPACT MRI 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 |
| Subsequent Product Code | JEC |
| Subsequent Product Code | LXT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-27 |
| Decision Date | 2005-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613154280209 | K053038 | 000 |
| 04546540492692 | K053038 | 000 |
| 04546540492708 | K053038 | 000 |
| 04546540492715 | K053038 | 000 |
| 04546540492722 | K053038 | 000 |
| 04546540492739 | K053038 | 000 |
| 04546540492746 | K053038 | 000 |
| 04546540492753 | K053038 | 000 |
| 04546540492906 | K053038 | 000 |
| 04546540492913 | K053038 | 000 |
| 04546540492920 | K053038 | 000 |
| 04546540495129 | K053038 | 000 |
| 07613154280162 | K053038 | 000 |
| 07613154280186 | K053038 | 000 |
| 04546540492685 | K053038 | 000 |