510(k) K221792

Acute QC Strut and Components by Smith & Nephew, Inc. — Product Code OSN

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 25, 2022
Date Received: June 21, 2022
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

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510(k) K221792

Clearance Details

Device Classification

Other clearances by Smith & Nephew, Inc.

Other clearances for product code OSN