FDA 510(k) Applications for Medical Device Product Code "LZK"
(Implant, Malar)

FDA 510(k) Number Applicant Device Name Decision Date
K021419 AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. AART MALAR IMPLANT 07/02/2002
K971479 ALLIED BIOMEDICAL CORP. DURALASTIC ANATOMICAL MALAR IMPLANTS 07/18/1997
K960362 CERAMED CORP. PERMAMESH HYDROXYLAPATITE MATRIX 03/20/1996
K960354 CERAMED CORP. PERMAMESH-D HYDROXYLAPATITE MATRIX 03/20/1996
K973574 HANSON MEDICAL, INC. DURALASTIC ANATOMICAL MALAR IMPLANT 10/24/1997
K002886 IMPLANTECH ASSOCIATES, INC. IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL) 11/24/2000
K973502 IMPLANTECH ASSOCIATES, INC. IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT 11/07/1997
K962261 IMPLANTECH ASSOCIATES, INC. IMPLANTECH WM NASAL-LABIAL IMPLANT 08/19/1996
K961511 LIFECORE BIOMEDICAL, INC. HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER 06/28/1996
K970400 ORTHOFIX, INC. BONE SOURCE HYDROXYAPATITE 05/02/1997
K992240 PILLAR SURGICAL, INC. PILLAR MALAR IMPLANT 11/22/1999
K961080 RAND SCIENTIFIC CORP. MEDIAL MALAR IMPLANT 04/19/1996
K982763 SEARE BIOMEDICAL CORP. SEARE BIOMEDICAL MALAR IMPLANTS 09/30/1998
K981835 SILIMED, LLC. SILIMED MALAR IMPLANT 07/09/1998
K980140 SPECTRUM DESIGNS, INC. SPECTRUM DESIGNS MEDIAL MALAR IMPLANT 03/03/1998
K980139 SPECTRUM DESIGNS, INC. SPECTRUM DESIGNS PROFILE MALAR IMPLANT 03/03/1998
K980141 SPECTRUM DESIGNS, INC. SPECTRUM DESIGNS PROJECTION MALAR IMPLANT 03/03/1998
K964443 SURGICAL TECHNOLOGY LABORATORIES, INC. SURGIFORM ANATOMICAL MALAR 12/20/1996
K983756 SURGICAL TECHNOLOGY LABORATORIES, INC. SURGIFORM ANATOMICAL MALAR 11/20/1998
K961210 W.L. GORE & ASSOCIATES,INC SAM FACIAL IMPLANT 06/19/1996


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