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510(k) K180539

Deformity Analysis and Correction Software (DACS) and Instrumentation by Arrowhead Medical Device Technologies, LLC — Product Code OSN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2018
Date Received
February 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

Other clearances by Arrowhead Medical Device Technologies, LLC

  • K112675 — ARROW-LOK DIGITAL SYSTEM (December 12, 2011)

Other clearances for product code OSN

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  • K221792 — Acute QC Strut and Components (August 25, 2022)
  • K140550 — ORTHOHUB EXTERNAL FIXATOR SOFTWARE (August 25, 2014)