LZK · Class II · 21 CFR 878.3550

FDA Product Code LZK: Implant, Malar

Leading manufacturers include Implantech Associates, Inc., Spectrum Designs, Inc. and Byron Medical.

40
Total
40
Cleared
67d
Avg days
1986
Since

FDA 510(k) Cleared Implant, Malar Devices (Product Code LZK)

40 devices
1–24 of 40
Cleared Nov 24, 2000
IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)
K002886
Implantech Associates, Inc.
General & Plastic Surgery · 70d
Cleared Nov 22, 1999
PILLAR MALAR IMPLANT
K992240
Pillar Surgical, Inc.
General & Plastic Surgery · 143d
Cleared Nov 20, 1998
SURGIFORM ANATOMICAL MALAR
K983756
Surgical Technology Laboratories, Inc.
General & Plastic Surgery · 29d
Cleared Sep 30, 1998
SEARE BIOMEDICAL MALAR IMPLANTS
K982763
Seare Biomedical Corp.
General & Plastic Surgery · 55d
Cleared Jul 09, 1998
SILIMED MALAR IMPLANT
K981835
Silimed, LLC
General & Plastic Surgery · 44d
Cleared Mar 03, 1998
SPECTRUM DESIGNS PROFILE MALAR IMPLANT
K980139
Spectrum Designs, Inc.
General & Plastic Surgery · 47d
Cleared Mar 03, 1998
SPECTRUM DESIGNS MEDIAL MALAR IMPLANT
K980140
Spectrum Designs, Inc.
General & Plastic Surgery · 47d
Cleared Mar 03, 1998
SPECTRUM DESIGNS PROJECTION MALAR IMPLANT
K980141
Spectrum Designs, Inc.
General & Plastic Surgery · 47d
Cleared Nov 07, 1997
IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT
K973502
Implantech Associates, Inc.
General & Plastic Surgery · 52d
Cleared Oct 24, 1997
DURALASTIC ANATOMICAL MALAR IMPLANT
K973574
Hanson Medical, Inc.
General & Plastic Surgery · 35d
Cleared Jul 18, 1997
DURALASTIC ANATOMICAL MALAR IMPLANTS
K971479
Allied Biomedical Corp.
General & Plastic Surgery · 86d
Cleared May 02, 1997
BONE SOURCE HYDROXYAPATITE
K970400
Orthofix, Inc.
General & Plastic Surgery · 88d
Cleared Dec 20, 1996
SURGIFORM ANATOMICAL MALAR
K964443
Surgical Technology Laboratories, Inc.
General & Plastic Surgery · 44d
Cleared Aug 19, 1996
IMPLANTECH WM NASAL-LABIAL IMPLANT
K962261
Implantech Associates, Inc.
General & Plastic Surgery · 68d
Cleared Jun 28, 1996
HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER
K961511
Lifecore Biomedical, Inc.
General & Plastic Surgery · 70d
Cleared Jun 19, 1996
SAM FACIAL IMPLANT
K961210
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 83d
Cleared Apr 19, 1996
MEDIAL MALAR IMPLANT
K961080
Rand Scientific Corp.
General & Plastic Surgery · 32d
Cleared Mar 20, 1996
PERMAMESH-D HYDROXYLAPATITE MATRIX
K960354
Ceramed Corp.
General & Plastic Surgery · 55d
Cleared Mar 20, 1996
PERMAMESH HYDROXYLAPATITE MATRIX
K960362
Ceramed Corp.
General & Plastic Surgery · 55d
Cleared Jan 27, 1995
IMPLANTECH NASAL LABIAL IMPLANT
K943988
Implantech Associates, Inc.
General & Plastic Surgery · 164d
Cleared Nov 04, 1994
MENISCUS CHIN IMPLANT
K944164
Spectrum Designs, Inc.
General & Plastic Surgery · 70d
Cleared Nov 04, 1994
SILHOUETTE MALAR IMPLANT
K944165
Spectrum Designs, Inc.
General & Plastic Surgery · 70d
Cleared Nov 04, 1994
DORSAL COLUMELLA IMPLANT
K944166
Spectrum Designs, Inc.
General & Plastic Surgery · 70d
Cleared Feb 03, 1994
ZARA ZONE IV MALAR IMPLANT MODIFICATION
K934233
Byron Medical
General & Plastic Surgery · 157d

About Product Code LZK - Regulatory Context