The following data is part of a premarket notification filed by Arrowhead Medical Device Technologies, Llc with the FDA for Deformity Analysis And Correction Software (dacs) And Instrumentation.
| Device ID | K180539 |
| 510k Number | K180539 |
| Device Name: | Deformity Analysis And Correction Software (DACS) And Instrumentation |
| Classification | Software For Diagnosis/treatment |
| Applicant | Arrowhead Medical Device Technologies, LLC 328 Poplar View Lane East, Suite 2 Collierville, TN 38017 |
| Contact | Thomas J. Twardzik |
| Correspondent | Thomas J. Twardzik Arrowhead Medical Device Technologies, LLC 328 Poplar View Lane East, Suite 2 Collierville, TN 38017 |
| Product Code | OSN |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-28 |
| Decision Date | 2018-08-13 |
| Summary: | summary |