Product Code: LZK FDA class 2 21 CFR 878.3550

Implant, Malar

General, Plastic Surgery

The Malar Implant (product code LZK) is a surgically placed device used to augment the cheekbone (malar) region of the face for cosmetic or reconstructive purposes, restoring facial contour following trauma or providing aesthetic enhancement. Regulated under 21 CFR 878.3550 and classified as a Class 2 device, it requires a 510(k) premarket notification and is flagged as an implant. The device falls under the General and Plastic Surgery specialty. It is not life-sustaining.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: LZK
Device Class: FDA class 2
Regulation Number: 878.3550
Medical Specialty: General, Plastic Surgery
Review Panel: SU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 40 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K021419	AART MALAR IMPLANT	Jul 02, 2002	Substantially Equivalent	Aesthetic and Reconstructive Technologies, Inc.
K002886	IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)	Nov 24, 2000	Substantially Equivalent	Implantech Associates, Inc.
K992240	PILLAR MALAR IMPLANT	Nov 22, 1999	Substantially Equivalent	Pillar Surgical, Inc.
K983756	SURGIFORM ANATOMICAL MALAR	Nov 20, 1998	Substantially Equivalent	Surgical Technology Laboratories, Inc.
K982763	SEARE BIOMEDICAL MALAR IMPLANTS	Sep 30, 1998	Substantially Equivalent	Seare Biomedical Corp.
K981835	SILIMED MALAR IMPLANT	Jul 09, 1998	Substantially Equivalent	Silimed, LLC
K980141	SPECTRUM DESIGNS PROJECTION MALAR IMPLANT	Mar 03, 1998	Substantially Equivalent	Spectrum Designs, Inc.
K980140	SPECTRUM DESIGNS MEDIAL MALAR IMPLANT	Mar 03, 1998	Substantially Equivalent	Spectrum Designs, Inc.
K980139	SPECTRUM DESIGNS PROFILE MALAR IMPLANT	Mar 03, 1998	Substantially Equivalent	Spectrum Designs, Inc.
K973502	IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT	Nov 07, 1997	Substantially Equivalent	Implantech Associates, Inc.
K973574	DURALASTIC ANATOMICAL MALAR IMPLANT	Oct 24, 1997	Substantially Equivalent	Hanson Medical, Inc.
K971479	DURALASTIC ANATOMICAL MALAR IMPLANTS	Jul 18, 1997	Substantially Equivalent	Allied Biomedical Corp.
K970400	BONE SOURCE HYDROXYAPATITE	May 02, 1997	Substantially Equivalent	Orthofix, Inc.
K964443	SURGIFORM ANATOMICAL MALAR	Dec 20, 1996	Substantially Equivalent	Surgical Technology Laboratories, Inc.
K962261	IMPLANTECH WM NASAL-LABIAL IMPLANT	Aug 19, 1996	Substantially Equivalent	Implantech Associates, Inc.
K961511	HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER	Jun 28, 1996	Substantially Equivalent	Lifecore Biomedical, Inc.
K961210	SAM FACIAL IMPLANT	Jun 19, 1996	Substantially Equivalent	W. L. Gore & Associates, Inc.
K961080	MEDIAL MALAR IMPLANT	Apr 19, 1996	Substantially Equivalent	Rand Scientific Corp.
K960362	PERMAMESH HYDROXYLAPATITE MATRIX	Mar 20, 1996	Substantially Equivalent	Ceramed Corp.
K960354	PERMAMESH-D HYDROXYLAPATITE MATRIX	Mar 20, 1996	Substantially Equivalent	Ceramed Corp.
K943988	IMPLANTECH NASAL LABIAL IMPLANT	Jan 27, 1995	Substantially Equivalent	Implantech Associates, Inc.
K944166	DORSAL COLUMELLA IMPLANT	Nov 04, 1994	Substantially Equivalent	Spectrum Designs, Inc.
K944165	SILHOUETTE MALAR IMPLANT	Nov 04, 1994	Substantially Equivalent	Spectrum Designs, Inc.
K944164	MENISCUS CHIN IMPLANT	Nov 04, 1994	Substantially Equivalent	Spectrum Designs, Inc.
K942421	IMPLANTECH LATERAL MANDIBULAR BAR IMPLANT	Aug 08, 1994	Substantially Equivalent	King & Spalding
K942420	IMPLANTECH MIDFACE-SUBMALAR LE FORT IMPLANT	Aug 08, 1994	Substantially Equivalent	King & Spalding
K934233	ZARA ZONE IV MALAR IMPLANT MODIFICATION	Feb 03, 1994	Substantially Equivalent	Byron Medical
K921582	FLOWERS MEDIAL MALAR IMPLANT	May 06, 1992	Substantially Equivalent	Implantech Associates, Inc.
K914016	ZARA ZONE IV MALAR IMPLANT	Dec 05, 1991	Substantially Equivalent	Byron Medical
K911515	EXTENDED MALAR IMPLANT	Jul 01, 1991	Substantially Equivalent	Implantech Associates, Inc.
K911513	TRAPEZOIDAL MALAR IMPLANT	Jul 01, 1991	Substantially Equivalent	Implantech Associates, Inc.
K910655	COMBINED MALAR IMPLANT	Mar 28, 1991	Substantially Equivalent	Implantech Associates, Inc.
K904348	CUI FEATHERED SILICONE MALAR	Nov 26, 1990	Substantially Equivalent	Cui Corp.
K902284	ZYMALAR IMPLANT	Sep 12, 1990	Substantially Equivalent	Applied Biomaterial Technologies
K903329	CUI ANATOMICAL SILICONE MALAR	Sep 10, 1990	Substantially Equivalent	Cui Corp.
K901662	ANATOMICAL MALAR IMPLANT	May 01, 1990	Substantially Equivalent	Implantech Associates, Inc.
K895152	BINDER SUBMALAR FACIAL IMPLANT II	Oct 27, 1989	Substantially Equivalent	Implantech Associates, Inc.
K894493	BINDER SUBMALAR FACIAL IMPLANT	Oct 27, 1989	Substantially Equivalent	Implantech Associates, Inc.
K873434	CREAT BRAND MALAR IMPLANT	Sep 11, 1987	Substantially Equivalent	Aesthetech Corp.
K863400	BYRON EXTENDED MALAR AND BYRON CONTOURED MALAR	Sep 17, 1986	Substantially Equivalent	Byron Medical