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510(k) K232878

TransLoc 3D by Foundation Fusion Solutions, LLC (Dba Cornerloc) — Product Code OUR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2023
Date Received
September 18, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sacroiliac Joint Fixation
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

sacroiliac joint fusion

Other clearances by Foundation Fusion Solutions, LLC (Dba Cornerloc)

  • K211496 — TransLoc 3D (July 27, 2022)

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