LZK · Class II · 21 CFR 878.3550

FDA Product Code LZK: Implant, Malar

Leading manufacturers include Implantech Associates, Inc., W.L. Gore & Associates, Inc. and Lifecore Biomedical, Inc..

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 07, 1997
IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT
K973502
Implantech Associates, Inc.
General & Plastic Surgery · 52d
Cleared May 02, 1997
BONE SOURCE HYDROXYAPATITE
K970400
Orthofix, Inc.
General & Plastic Surgery · 88d
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 Jan 27, 1995
IMPLANTECH NASAL LABIAL IMPLANT
K943988
Implantech Associates, Inc.
General & Plastic Surgery · 164d
Cleared May 06, 1992
FLOWERS MEDIAL MALAR IMPLANT
K921582
Implantech Associates, Inc.
General & Plastic Surgery · 34d
Cleared Jul 01, 1991
TRAPEZOIDAL MALAR IMPLANT
K911513
Implantech Associates, Inc.
General & Plastic Surgery · 88d
Cleared Jul 01, 1991
EXTENDED MALAR IMPLANT
K911515
Implantech Associates, Inc.
General & Plastic Surgery · 88d
Cleared Mar 28, 1991
COMBINED MALAR IMPLANT
K910655
Implantech Associates, Inc.
General & Plastic Surgery · 42d
Cleared May 01, 1990
ANATOMICAL MALAR IMPLANT
K901662
Implantech Associates, Inc.
General & Plastic Surgery · 21d
Cleared Oct 27, 1989
BINDER SUBMALAR FACIAL IMPLANT
K894493
Implantech Associates, Inc.
General & Plastic Surgery · 100d
Cleared Oct 27, 1989
BINDER SUBMALAR FACIAL IMPLANT II
K895152
Implantech Associates, Inc.
General & Plastic Surgery · 78d

About Product Code LZK - Regulatory Context