The following data is part of a premarket notification filed by Arrowhead De, Llc with the FDA for Accessories For The Sixfix® Hexapod Fixator.
| Device ID | K200123 |
| 510k Number | K200123 |
| Device Name: | Accessories For The SixFix® Hexapod Fixator |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | Arrowhead DE, LLC 328 Poplar View Lane East, Suite 2 Collierville, TN 38017 |
| Contact | Thomas J. Twardzik |
| Correspondent | Thomas J. Twardzik Arrowhead DE, LLC 328 Poplar View Lane East, Suite 2 Collierville, TN 38017 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-21 |
| Decision Date | 2020-09-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850030203120 | K200123 | 000 |
| 00850030203625 | K200123 | 000 |
| 00850030203632 | K200123 | 000 |
| 00850030203649 | K200123 | 000 |
| 00850030203137 | K200123 | 000 |
| 00850030203144 | K200123 | 000 |
| 00850030203014 | K200123 | 000 |
| 00850030203021 | K200123 | 000 |
| 00850030203106 | K200123 | 000 |
| 00850030203113 | K200123 | 000 |
| 00850030203618 | K200123 | 000 |