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FDA 510(k), K211496, TransLoc 3D
FDA 510(k), K211496, TransLoc 3D
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510(K) Number: K211496
Device Name: TransLoc 3D
Manufacturer: Foundation Fusion Solutions, LLC (dba CornerLoc)
Device Classification Name: Sacroiliac Joint Fixation
Regulation Number: 888.3040
Classification Product Code: OUR
Date Received: 05/13/2021
Decision Date: 07/27/2022
Regulation Medical Specialty: Orthopedic
Device Name: TransLoc 3D
Manufacturer: Foundation Fusion Solutions, LLC (dba CornerLoc)
Device Classification Name: Sacroiliac Joint Fixation
Regulation Number: 888.3040
Classification Product Code: OUR
Date Received: 05/13/2021
Decision Date: 07/27/2022
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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