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

Implant, Malar

21 CFR 878.3550 / General, Plastic Surgery
FDA source (opens on fda.gov)

LZK is the FDA product code for Implant, Malar, a class II device type, regulated under 21 CFR 878.3550. As of , FDA records hold 40 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
LZK
Device name
Implant, Malar
Regulation
21 CFR 878.3550
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
40
Ingested recalls
4

Clearances, product code LZK

By decision year
40 clearances under product code LZK with a decision year between 1986 and 2002, 1996 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code LZK by decision year
YearClearances
19861
19871
19892
19904
19914
19921
19946
19951
19967
19974
19986
19991
20001
20021

Applicants with the most clearances

Product code LZK
Applicants holding the most 510(k) clearances under product code LZK
ApplicantClearances
Implantech Associates Inc11
Spectrum Designs, Inc.6
Byron Medical3
Ceramed Corp.2
Cui Corp.2
King & Spalding2
Surgical Technology Laboratories Inc.2
Aesthetech Corp.1
Aesthetic and Reconstructive Technologies, Inc.1
Allied Biomedical Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code