510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K032344Substantially Equivalent

The Hedrocel Trabecular Metal Reconstruction System Model 10-330

Implex Corp., Allendale NJ / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K032344 is the FDA 510(k) clearance record for THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330, a class II device, cleared for Implex Corp. on under FDA product code EZX (Mesh, Surgical, Metal). FDA records list 65 510(k) clearances for Implex Corp., from to . As of , FDA records show no recalls naming K032344.

Clearance record

Decision date
Received
(64 days to decision)
Product code
EZX Mesh, Surgical, Metal
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Implex Corp. 80 Commerce Dr., Allendale NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EZX

Trailing 12 months

FDA records hold no clearances under product code EZX in the trailing twelve months.

FDA records show no clearances under product code EZX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EZX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260