510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001254Substantially Equivalent

Orthomatrix, Inc. Cerclage System

Orthomatrix, Inc., Collierville TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001254 is the FDA 510(k) clearance record for ORTHOMATRIX, INC. CERCLAGE SYSTEM, a class II device, cleared for Orthomatrix, Inc. on under FDA product code JDQ (Cerclage, Fixation). FDA records list 8 510(k) clearances for Orthomatrix, Inc., from to . As of , FDA records show no recalls naming K001254.

Clearance record

Decision date
Received
(238 days to decision)
Product code
JDQ Cerclage, Fixation
Regulation
21 CFR 888.3010
Device class
Class II
Review panel
Orthopedic
Applicant
Orthomatrix, Inc. 711 Chaney Cove, Collierville TN
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