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510(k) K211496

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2022
Date Received
May 13, 2021
Clearance Type
Traditional
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)

  • K232878 — TransLoc 3D (October 17, 2023)

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