The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Hoffmann Ii External Fixation System.
| Device ID | K000957 |
| 510k Number | K000957 |
| Device Name: | HOFFMANN II EXTERNAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Karen Ariemma |
| Correspondent | Karen Ariemma HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | LXT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-24 |
| Decision Date | 2000-05-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327095210 | K000957 | 000 |
| 04546540383044 | K000957 | 000 |
| 07613327088755 | K000957 | 000 |
| 07613327088779 | K000957 | 000 |
| 07613327088786 | K000957 | 000 |
| 07613327089134 | K000957 | 000 |
| 07613327091472 | K000957 | 000 |
| 07613327091489 | K000957 | 000 |
| 07613327095203 | K000957 | 000 |
| 04546540383037 | K000957 | 000 |