510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K922142Substantially Equivalent

Fx-Cablelok System

Bio-Tech Co., Arlington VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K922142 is the FDA 510(k) clearance record for FX-CABLELOK SYSTEM, a class II device, cleared for Bio-Tech Co. on under FDA product code JDQ (Cerclage, Fixation). FDA records list 2 510(k) clearances for Bio-Tech Co., from to . As of , FDA records show no recalls naming K922142.

Clearance record

Decision date
Received
(198 days to decision)
Product code
JDQ Cerclage, Fixation
Regulation
21 CFR 888.3010
Device class
Class II
Review panel
Orthopedic
Applicant
Bio-Tech Co. 727 Twenty-Third St. S., Arlington VA
510(k) summary
Statement
Third party review
No

Clearances, product code JDQ

Trailing 12 months
1 clearance under product code JDQ in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JDQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260