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510(k) K233315

HipXpert and HipInsight System by Surgical Planning Associates, Inc. — Product Code OSF

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 8, 2024
Date Received: September 29, 2023
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Patient Specific Manual Orthopedic Stereotaxic System
Device Class: Class II
Regulation Number: 882.4560
Review Panel: OR
Submission Type

Intended for defining orthopedic acetabular implant alignment relative to a patient's anatomy.