The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Hoffmann Ii Dynamization/distraction Rod-to-rod Coupling.
| Device ID | K003211 |
| 510k Number | K003211 |
| Device Name: | HOFFMANN II DYNAMIZATION/DISTRACTION ROD-TO-ROD COUPLING |
| 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 | 2000-10-13 |
| Decision Date | 2000-12-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327094978 | K003211 | 000 |