510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K180249Substantially Equivalent

OmniPore DUROMAX Surgical Implants

Matrix Surgical Holdings, LLC/Matrix Surgical USA, Atlanta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K180249 is the FDA 510(k) clearance record for OmniPore DUROMAX Surgical Implants, a class II device, cleared for Matrix Surgical Holdings, LLC/Matrix Surgical USA on under FDA product code JEY (Plate, Bone). FDA records list 2 510(k) clearances for Matrix Surgical Holdings, LLC/Matrix Surgical USA, from to . As of , FDA records show no recalls naming K180249.

Clearance record

Decision date
Received
(255 days to decision)
Product code
JEY Plate, Bone
Regulation
21 CFR 872.4760
Device class
Class II
Review panel
Dental
Applicant
Matrix Surgical Holdings, LLC/Matrix Surgical USA 4025 Welcome All Rd., Atlanta GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JEY

Trailing 12 months
5 clearances under product code JEY in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JEY, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20261
August 20261
September 20260
October 20260