510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K943378Substantially Equivalent

Implex Cement Restrictor System

Implex Corp., Allendale NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943378 is the FDA 510(k) clearance record for IMPLEX CEMENT RESTRICTOR SYSTEM, a class II device, cleared for Implex Corp. on under FDA product code LZN (Cement Obturator). FDA records list 65 510(k) clearances for Implex Corp., from to . As of , FDA records show no recalls naming K943378.

Clearance record

Decision date
Received
(72 days to decision)
Product code
LZN Cement Obturator
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
Third party review
No

Clearances, product code LZN

Trailing 12 months

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

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