510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K214123Substantially Equivalent

T-FIX® 3DSI Joint Fusion System

Cutting Edge Spine, Mineral Springs NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K214123 is the FDA 510(k) clearance record for T-FIX® 3DSI Joint Fusion System, a class II device, cleared for Cutting Edge Spine, LLC on under FDA product code OUR (Sacroiliac Joint Fixation). FDA's definition for product code OUR reads: "sacroiliac joint fusion". FDA records list 11 510(k) clearances for Cutting Edge Spine, LLC, from to . As of , FDA records show no recalls naming K214123.

Clearance record

Decision date
Received
(176 days to decision)
Product code
OUR Sacroiliac Joint Fixation
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Cutting Edge Spine, LLC 6012 Waxhaw Hwy., Mineral Springs NC
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