Product code LZK— General, Plastic Surgery

FDA has cleared 40 devices under product code LZK between 1986 and 2002, filed by 19 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20021 clearance
• 20001 clearance
• 19991 clearance
• 19986 clearances
• 19974 clearances
• 19967 clearances
• 19951 clearance
• 19946 clearances
• 19921 clearance
• 19914 clearances
• 19904 clearances
• 19892 clearances
• 19871 clearance
• 19861 clearance

• Implantech Associates, Inc.11 clearances
• Spectrum Designs, Inc.6 clearances
• Byron Medical3 clearances
• Surgical Technology Laboratories, Inc.2 clearances
• King & Spalding2 clearances
• Cui Corp.2 clearances
• Ceramed Corp.2 clearances
• W. L. Gore & Associates, Inc.1 clearance
• Silimed, LLC1 clearance
• Seare Biomedical Corp.1 clearance

• K021419 — AART MALAR IMPLANTAesthetic and Reconstructive Technologies, Inc.·2002-07-02
• K002886 — IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)Implantech Associates, Inc.·2000-11-24
• K992240 — PILLAR MALAR IMPLANTPillar Surgical, Inc.·1999-11-22
• K983756 — SURGIFORM ANATOMICAL MALARSurgical Technology Laboratories, Inc.·1998-11-20
• K982763 — SEARE BIOMEDICAL MALAR IMPLANTSSeare Biomedical Corp.·1998-09-30
• K981835 — SILIMED MALAR IMPLANTSilimed, LLC·1998-07-09
• K980139 — SPECTRUM DESIGNS PROFILE MALAR IMPLANTSpectrum Designs, Inc.·1998-03-03
• K980140 — SPECTRUM DESIGNS MEDIAL MALAR IMPLANTSpectrum Designs, Inc.·1998-03-03
• K980141 — SPECTRUM DESIGNS PROJECTION MALAR IMPLANTSpectrum Designs, Inc.·1998-03-03
• K973502 — IMPLANTECH CONFORM BINDER SUBMALAR IMPLANTImplantech Associates, Inc.·1997-11-07
• K973574 — DURALASTIC ANATOMICAL MALAR IMPLANTHanson Medical, Inc.·1997-10-24
• K971479 — DURALASTIC ANATOMICAL MALAR IMPLANTSAllied Biomedical Corp.·1997-07-18
• K970400 — BONE SOURCE HYDROXYAPATITEOrthofix, Inc.·1997-05-02
• K964443 — SURGIFORM ANATOMICAL MALARSurgical Technology Laboratories, Inc.·1996-12-20
• K962261 — IMPLANTECH WM NASAL-LABIAL IMPLANTImplantech Associates, Inc.·1996-08-19
• K961511 — HAPSET HYDROXYLAPATITE BONE GRAFT PLASTERLifecore Biomedical, Inc.·1996-06-28
• K961210 — SAM FACIAL IMPLANTW. L. Gore & Associates, Inc.·1996-06-19
• K961080 — MEDIAL MALAR IMPLANTRand Scientific Corp.·1996-04-19
• K960354 — PERMAMESH-D HYDROXYLAPATITE MATRIXCeramed Corp.·1996-03-20
• K960362 — PERMAMESH HYDROXYLAPATITE MATRIXCeramed Corp.·1996-03-20
• K943988 — IMPLANTECH NASAL LABIAL IMPLANTImplantech Associates, Inc.·1995-01-27
• K944164 — MENISCUS CHIN IMPLANTSpectrum Designs, Inc.·1994-11-04
• K944165 — SILHOUETTE MALAR IMPLANTSpectrum Designs, Inc.·1994-11-04
• K944166 — DORSAL COLUMELLA IMPLANTSpectrum Designs, Inc.·1994-11-04
• K942420 — IMPLANTECH MIDFACE-SUBMALAR LE FORT IMPLANTKing & Spalding·1994-08-08
• K942421 — IMPLANTECH LATERAL MANDIBULAR BAR IMPLANTKing & Spalding·1994-08-08
• K934233 — ZARA ZONE IV MALAR IMPLANT MODIFICATIONByron Medical·1994-02-03
• K921582 — FLOWERS MEDIAL MALAR IMPLANTImplantech Associates, Inc.·1992-05-06
• K914016 — ZARA ZONE IV MALAR IMPLANTByron Medical·1991-12-05
• K911513 — TRAPEZOIDAL MALAR IMPLANTImplantech Associates, Inc.·1991-07-01
• K911515 — EXTENDED MALAR IMPLANTImplantech Associates, Inc.·1991-07-01
• K910655 — COMBINED MALAR IMPLANTImplantech Associates, Inc.·1991-03-28
• K904348 — CUI FEATHERED SILICONE MALARCui Corp.·1990-11-26
• K902284 — ZYMALAR IMPLANTApplied Biomaterial Technologies·1990-09-12
• K903329 — CUI ANATOMICAL SILICONE MALARCui Corp.·1990-09-10
• K901662 — ANATOMICAL MALAR IMPLANTImplantech Associates, Inc.·1990-05-01
• K894493 — BINDER SUBMALAR FACIAL IMPLANTImplantech Associates, Inc.·1989-10-27
• K895152 — BINDER SUBMALAR FACIAL IMPLANT IIImplantech Associates, Inc.·1989-10-27
• K873434 — CREAT BRAND MALAR IMPLANTAesthetech Corp.·1987-09-11
• K863400 — BYRON EXTENDED MALAR AND BYRON CONTOURED MALARByron Medical·1986-09-17