510(k) K180539
K180539 is an FDA 510(k) premarket notification submitted by Arrowhead Medical Device Technologies, LLC for the device "Deformity Analysis and Correction Software (DACS) and Instrumentation". The FDA issued a decision of Substantially Equivalent on Aug 13, 2018. The device falls under product code OSN (Software For Diagnosis/Treatment), a Class II device regulated under 21 CFR 888.3030. Arrowhead Medical Device Technologies, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 13, 2018
- Date Received
- Feb 28, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Software For Diagnosis/Treatment
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type
Software associated with an orthopedic trauma device which is intended for the diagnosis or treatment of traumatic or reconstructive orthopedic conditions