Atlas FDA

LZK

40 FDA 510(k) clearances · Product code

68 daysmedian time to decision
113 days90th percentile
40clearances measured

FDA profile

Official device name
Implant, Malar
Device class
Class II (moderate risk)
Regulation
21 CFR 878.3550
Medical specialty
General, Plastic Surgery
Flags
Implant
Adverse events (MAUDE)
2001: 2 · 2005: 2 · 2007: 10 · 2008: 5 · 2010: 4 · 2012: 7
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
AART MALAR IMPLANT (K021419)Aesthetic and Reconstructive Technologies, Inc.2002-07-02
IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL) (K002886)Implantech Associates, Inc.2000-11-24
PILLAR MALAR IMPLANT (K992240)Pillar Surgical, Inc.1999-11-22
SURGIFORM ANATOMICAL MALAR (K983756)Surgical Technology Laboratories, Inc.1998-11-20
SEARE BIOMEDICAL MALAR IMPLANTS (K982763)Seare Biomedical Corp.1998-09-30
SILIMED MALAR IMPLANT (K981835)Silimed, LLC1998-07-09
SPECTRUM DESIGNS PROFILE MALAR IMPLANT (K980139)Spectrum Designs, Inc.1998-03-03
SPECTRUM DESIGNS PROJECTION MALAR IMPLANT (K980141)Spectrum Designs, Inc.1998-03-03
SPECTRUM DESIGNS MEDIAL MALAR IMPLANT (K980140)Spectrum Designs, Inc.1998-03-03
IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT (K973502)Implantech Associates, Inc.1997-11-07
DURALASTIC ANATOMICAL MALAR IMPLANT (K973574)Hanson Medical, Inc.1997-10-24
DURALASTIC ANATOMICAL MALAR IMPLANTS (K971479)Allied Biomedical Corp.1997-07-18
BONE SOURCE HYDROXYAPATITE (K970400)Orthofix, Inc.1997-05-02
SURGIFORM ANATOMICAL MALAR (K964443)Surgical Technology Laboratories, Inc.1996-12-20
IMPLANTECH WM NASAL-LABIAL IMPLANT (K962261)Implantech Associates, Inc.1996-08-19
HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER (K961511)Lifecore Biomedical, Inc.1996-06-28
SAM FACIAL IMPLANT (K961210)W. L. Gore & Associates, Inc.1996-06-19
MEDIAL MALAR IMPLANT (K961080)Rand Scientific Corp.1996-04-19
PERMAMESH HYDROXYLAPATITE MATRIX (K960362)Ceramed Corp.1996-03-20
PERMAMESH-D HYDROXYLAPATITE MATRIX (K960354)Ceramed Corp.1996-03-20
IMPLANTECH NASAL LABIAL IMPLANT (K943988)Implantech Associates, Inc.1995-01-27
SILHOUETTE MALAR IMPLANT (K944165)Spectrum Designs, Inc.1994-11-04
DORSAL COLUMELLA IMPLANT (K944166)Spectrum Designs, Inc.1994-11-04
MENISCUS CHIN IMPLANT (K944164)Spectrum Designs, Inc.1994-11-04
IMPLANTECH LATERAL MANDIBULAR BAR IMPLANT (K942421)King & Spalding1994-08-08
IMPLANTECH MIDFACE-SUBMALAR LE FORT IMPLANT (K942420)King & Spalding1994-08-08
ZARA ZONE IV MALAR IMPLANT MODIFICATION (K934233)Byron Medical1994-02-03
FLOWERS MEDIAL MALAR IMPLANT (K921582)Implantech Associates, Inc.1992-05-06
ZARA ZONE IV MALAR IMPLANT (K914016)Byron Medical1991-12-05
EXTENDED MALAR IMPLANT (K911515)Implantech Associates, Inc.1991-07-01
TRAPEZOIDAL MALAR IMPLANT (K911513)Implantech Associates, Inc.1991-07-01
COMBINED MALAR IMPLANT (K910655)Implantech Associates, Inc.1991-03-28
CUI FEATHERED SILICONE MALAR (K904348)Cui Corp.1990-11-26
ZYMALAR IMPLANT (K902284)Applied Biomaterial Technologies1990-09-12
CUI ANATOMICAL SILICONE MALAR (K903329)Cui Corp.1990-09-10
ANATOMICAL MALAR IMPLANT (K901662)Implantech Associates, Inc.1990-05-01
BINDER SUBMALAR FACIAL IMPLANT (K894493)Implantech Associates, Inc.1989-10-27
BINDER SUBMALAR FACIAL IMPLANT II (K895152)Implantech Associates, Inc.1989-10-27
CREAT BRAND MALAR IMPLANT (K873434)Aesthetech Corp.1987-09-11
BYRON EXTENDED MALAR AND BYRON CONTOURED MALAR (K863400)Byron Medical1986-09-17

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