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LZK — Implant, Malar Class II

FDA Device Classification

Classification Details

Product Code
LZK
Device Class
Class II
Regulation Number
878.3550
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K021419aesthetic and reconstructive technologiesAART MALAR IMPLANTJuly 2, 2002
K002886implantech associatesIMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)November 24, 2000
K992240pillar surgicalPILLAR MALAR IMPLANTNovember 22, 1999
K983756surgical technology laboratoriesSURGIFORM ANATOMICAL MALARNovember 20, 1998
K982763seare biomedicalSEARE BIOMEDICAL MALAR IMPLANTSSeptember 30, 1998
K981835silimedSILIMED MALAR IMPLANTJuly 9, 1998
K980140spectrum designsSPECTRUM DESIGNS MEDIAL MALAR IMPLANTMarch 3, 1998
K980141spectrum designsSPECTRUM DESIGNS PROJECTION MALAR IMPLANTMarch 3, 1998
K980139spectrum designsSPECTRUM DESIGNS PROFILE MALAR IMPLANTMarch 3, 1998
K973502implantech associatesIMPLANTECH CONFORM BINDER SUBMALAR IMPLANTNovember 7, 1997
K973574hanson medicalDURALASTIC ANATOMICAL MALAR IMPLANTOctober 24, 1997
K971479allied biomedicalDURALASTIC ANATOMICAL MALAR IMPLANTSJuly 18, 1997
K970400orthofixBONE SOURCE HYDROXYAPATITEMay 2, 1997
K964443surgical technology laboratoriesSURGIFORM ANATOMICAL MALARDecember 20, 1996
K962261implantech associatesIMPLANTECH WM NASAL-LABIAL IMPLANTAugust 19, 1996
K961511lifecore biomedicalHAPSET HYDROXYLAPATITE BONE GRAFT PLASTERJune 28, 1996
K961210w.l. gore and associatesSAM FACIAL IMPLANTJune 19, 1996
K961080rand scientificMEDIAL MALAR IMPLANTApril 19, 1996
K960354ceramedPERMAMESH-D HYDROXYLAPATITE MATRIXMarch 20, 1996
K960362ceramedPERMAMESH HYDROXYLAPATITE MATRIXMarch 20, 1996