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510(k) K201676

Barricaid Instrument Tray by Intrinsic Therapeutics, Inc. — Product Code QHG

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 16, 2020
Date Received: June 19, 2020
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Defect Measurement Tool
Device Class: Class II
Regulation Number: 888.4510
Review Panel: OR
Submission Type

Manual surgical instrument for appropriate patient select for orthopedic implant is a device used to measure an anatomical feature(s) to determine appropriate patient selection for an orthopedic implant. The characteristics of the instrument are defined by the specifications set for use of the orthopedic implant in terms of geometry, surgical technique, and use of the device.