The following data is part of a premarket notification filed by Arrowhead De, Llc with the FDA for Arrowhead Mini-rail Fixator.
| Device ID | K162032 |
| 510k Number | K162032 |
| Device Name: | Arrowhead Mini-Rail 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 |
| Subsequent Product Code | HTY |
| Subsequent Product Code | JDW |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-22 |
| Decision Date | 2017-02-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850030203915 | K162032 | 000 |
| 00850030203779 | K162032 | 000 |
| 00850030203762 | K162032 | 000 |
| 00850030203755 | K162032 | 000 |
| 00850030203748 | K162032 | 000 |
| 00850030203731 | K162032 | 000 |
| 00850030203724 | K162032 | 000 |
| 00850030203717 | K162032 | 000 |
| 00850030203700 | K162032 | 000 |
| 00850030203786 | K162032 | 000 |
| 00850030203793 | K162032 | 000 |
| 00850030203809 | K162032 | 000 |
| 00850030203908 | K162032 | 000 |
| 00850030203892 | K162032 | 000 |
| 00850030203885 | K162032 | 000 |
| 00850030203878 | K162032 | 000 |
| 00850030203847 | K162032 | 000 |
| 00850030203830 | K162032 | 000 |
| 00850030203823 | K162032 | 000 |
| 00850030203816 | K162032 | 000 |
| 00850030203694 | K162032 | 000 |