The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Hoffmann Ii Mri External Fixation System.
| Device ID | K051306 |
| 510k Number | K051306 |
| Device Name: | HOFFMANN II MRI EXTERNAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite |
| 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 | LXT |
| Subsequent Product Code | JEC |
| Subsequent Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-19 |
| Decision Date | 2005-06-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613154164134 | K051306 | 000 |
| 04546540492579 | K051306 | 000 |
| 04546540492586 | K051306 | 000 |
| 04546540492593 | K051306 | 000 |
| 04546540492609 | K051306 | 000 |
| 04546540492616 | K051306 | 000 |
| 04546540492623 | K051306 | 000 |
| 04546540492630 | K051306 | 000 |
| 04546540492845 | K051306 | 000 |
| 04546540492852 | K051306 | 000 |
| 04546540492869 | K051306 | 000 |
| 04546540492876 | K051306 | 000 |
| 04546540492883 | K051306 | 000 |
| 04546540492890 | K051306 | 000 |
| 04546540492562 | K051306 | 000 |