510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K911513Substantially Equivalent

Trapezoidal Malar Implant

Implantech Associates Inc, Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911513 is the FDA 510(k) clearance record for TRAPEZOIDAL MALAR IMPLANT, a class II device, cleared for Implantech Associates, Inc. on under FDA product code LZK (Implant, Malar). FDA records list 41 510(k) clearances for Implantech Associates, Inc., from to . As of , FDA records show no recalls naming K911513.

Clearance record

Decision date
Received
(88 days to decision)
Product code
LZK Implant, Malar
Regulation
21 CFR 878.3550
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Implantech Associates, Inc. 1730 Pennsylvania Ave., NW, Washington DC
Third party review
No

Clearances, product code LZK

Trailing 12 months

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

FDA records show no clearances under product code LZK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LZK, 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