510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K230446Substantially Equivalent

TiLink-L SI Joint Fusion System

Surgentec LLC, Boca Raton FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K230446 is the FDA 510(k) clearance record for TiLink-L SI Joint Fusion System, a class II device, cleared for SurGenTec, LLC on under FDA product code OUR (Sacroiliac Joint Fixation). FDA's definition for product code OUR reads: "sacroiliac joint fusion". FDA records list 29 510(k) clearances for SurGenTec, LLC, from to . As of , FDA records show no recalls naming K230446.

Clearance record

Decision date
Received
(106 days to decision)
Product code
OUR Sacroiliac Joint Fixation
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
SurGenTec, LLC 911 Clint Moore Rd., Boca Raton FL
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