The following data is part of a premarket notification filed by Arrowhead De, Llc with the FDA for Arrowhead Hexapod Fixator.
| Device ID | K190069 |
| 510k Number | K190069 |
| Device Name: | Arrowhead 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 | Patrick Mullaney Arrowhead DE, LLC 328 Poplar View Lane East, Suite 2 Collierville, TN 38017 |
| Product Code | KTT |
| Subsequent Product Code | HTY |
| Subsequent Product Code | OSN |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-15 |
| Decision Date | 2019-05-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855967006776 | K190069 | 000 |
| 00855967006592 | K190069 | 000 |
| 00855967006585 | K190069 | 000 |
| 00855967006578 | K190069 | 000 |
| 00855967006561 | K190069 | 000 |
| 00855967006554 | K190069 | 000 |
| 00855967006547 | K190069 | 000 |
| 00855967006530 | K190069 | 000 |
| 00855967006523 | K190069 | 000 |
| 00855967006516 | K190069 | 000 |
| 00855967006509 | K190069 | 000 |
| 00855967006493 | K190069 | 000 |
| 00855967006486 | K190069 | 000 |
| 00850030203960 | K190069 | 000 |
| 00850030203953 | K190069 | 000 |
| 00850030203946 | K190069 | 000 |
| 00855967006608 | K190069 | 000 |
| 00855967006615 | K190069 | 000 |
| 00855967006769 | K190069 | 000 |
| 00855967006752 | K190069 | 000 |
| 00855967006745 | K190069 | 000 |
| 00855967006738 | K190069 | 000 |
| 00855967006721 | K190069 | 000 |
| 00855967006714 | K190069 | 000 |
| 00855967006707 | K190069 | 000 |
| 00855967006691 | K190069 | 000 |
| 00855967006684 | K190069 | 000 |
| 00855967006677 | K190069 | 000 |
| 00855967006660 | K190069 | 000 |
| 00855967006653 | K190069 | 000 |
| 00855967006646 | K190069 | 000 |
| 00855967006639 | K190069 | 000 |
| 00855967006622 | K190069 | 000 |
| 00850030203939 | K190069 | 000 |