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510(k) K140550

ORTHOHUB EXTERNAL FIXATOR SOFTWARE by Orthohub, Inc. — Product Code OSN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2014
Date Received
March 4, 2014
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 for product code OSN

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  • K221792 — Acute QC Strut and Components (August 25, 2022)
  • K180539 — Deformity Analysis and Correction Software (DACS) and Instrumentation (August 13, 2018)