510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K141106Substantially Equivalent

Frontier Devices Fusio Screw Fuze System

Folsom Metal Products, Inc. dba Frontier Devices, Pelham AL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K141106 is the FDA 510(k) clearance record for FRONTIER DEVICES FUSIO SCREW FUZE SYSTEM, a class II device, cleared for Folsom Metal Products, Inc. Dba Frontier Devices on under FDA product code OUR (Sacroiliac Joint Fixation). FDA's definition for product code OUR reads: "sacroiliac joint fusion". FDA records list one 510(k) clearance for Folsom Metal Products, Inc. Dba Frontier Devices. As of , FDA records show no recalls naming K141106.

Clearance record

Decision date
Received
(164 days to decision)
Product code
OUR Sacroiliac Joint Fixation
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Folsom Metal Products, Inc. Dba Frontier Devices 153a Cahaba Valley Pkwy., Pelham AL
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