510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K981835Substantially Equivalent

Silimed Malar Implant

Silimed, LLC, Crofton MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981835 is the FDA 510(k) clearance record for SILIMED MALAR IMPLANT, a class II device, cleared for Silimed, LLC on under FDA product code LZK (Implant, Malar). FDA records list 10 510(k) clearances for Silimed, LLC, from to . As of , FDA records show no recalls naming K981835.

Clearance record

Decision date
Received
(44 days to decision)
Product code
LZK Implant, Malar
Regulation
21 CFR 878.3550
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Silimed, LLC P.O. Box 4341, Crofton MD
510(k) summary
Statement
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