510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
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K211496Substantially Equivalent

TransLoc 3D

Foundation Fusion Solutions, LLC (dba Cornerloc), Tulsa OK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K211496 is the FDA 510(k) clearance record for TransLoc 3D, a class II device, cleared for Foundation Fusion Solutions, LLC (Dba Cornerloc) on under FDA product code OUR (Sacroiliac Joint Fixation). FDA's definition for product code OUR reads: "sacroiliac joint fusion". FDA records list 2 510(k) clearances for Foundation Fusion Solutions, LLC (Dba Cornerloc), from to . As of , FDA records show no recalls naming K211496.

Clearance record

Decision date
Received
(440 days to decision)
Product code
OUR Sacroiliac Joint Fixation
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Foundation Fusion Solutions, LLC (Dba Cornerloc) 11916 S. Oxford Ave., Suite 206, Tulsa OK
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OUR

Trailing 12 months
6 clearances under product code OUR in the twelve months to October 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code OUR, trailing twelve months
MonthClearances
November 20251
December 20250
January 20262
February 20261
March 20260
April 20261
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260