Prosthesis, Chin, Internal

FDA product code FWP · 64 cleared devices

Class 2 General, Plastic Surgery

Regulation: 21 CFR 878.3550
Review panel: SU
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-11-02 – 2026-03-12

FWP 2026-03-12

MEDPOR Customized Implant Kit

Applicant Stryker Leibinger GmbH & Co KG

K number K254233

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FWP 2023-11-22

FITme Customized Silicone Implant

Applicant Keosan Trading Co.

K number K232593

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FWP 2020-12-23

Customized Contour Implant

Applicant Implantech Associates, Inc.

K number K200610

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FWP 2019-08-23

Customized Contour Implant

Applicant Implantech Associates, Inc.

K number K191130

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FWP 2019-08-15

Stryker CMF MEDPOR Priority Customized Implant Kit

Applicant Stryker Leibinger GmbH & Co KG

K number K191916

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FWP 2016-02-05

Stryker CMF MEDPOR Customized Implant

Applicant Stryker

K number K153508

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FWP 2016-01-20

SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant

Applicant Poriferous, LLC

K number K152463

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FWP 2012-11-01

STRYKER CMF MEDPOR CUSTOMIZED IMPLANT

Applicant Howmedica Osteonics Corp.

K number K121315

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FWP 2009-04-22

PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER)

Applicant Surgical Technology Laboratories, Inc ("Stl")

K number K091011

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FWP 2002-07-02

AART CHIN IMPLANT

Applicant Aesthetic and Reconstructive Technologies, Inc.

K number K021417

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FWP 2002-03-14

MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL

Applicant Porex Surgical, Inc.

K number K012350

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FWP 1999-11-22

PILLAR CHIN IMPLANT

Applicant Pillar Surgical, Inc.

K number K992239

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FWP 1998-11-20

STANDARD CHIN

Applicant Surgical Technology Laboratories, Inc.

K number K983754

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FWP 1998-09-30

SEARE BIOMEDICAL CHIN IMPLANTS

Applicant Seare Biomedical Corp.

K number K982752

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FWP 1998-07-09

SILIMED CHIN IMPLANTS

Applicant Silimed, LLC

K number K981850

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FWP 1998-05-06

SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT

Applicant Spectrum Designs, Inc.

K number K980463

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FWP 1998-05-06

SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANT

Applicant Spectrum Designs, Inc.

K number K980462

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FWP 1998-05-06

SPECTRUM DESIGNS ANTERIOR CHIN IMPLANT

Applicant Spectrum Designs, Inc.

K number K980446

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FWP 1998-05-06

SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT

Applicant Spectrum Designs, Inc.

K number K980445

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FWP 1998-05-06

SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT

Applicant Spectrum Designs, Inc.

K number K980444

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FWP 1998-04-03

SPECTRUM DESIGNS SYMMETRICAL CHIN IMPLANT

Applicant Spectrum Designs, Inc.

K number K980138

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FWP 1998-03-04

SPECTRUM DESIGNS CLEFT CHIN IMPLANT

Applicant Spectrum Designs, Inc.

K number K980461

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FWP 1997-11-07

DURALASTIC ANATOMICAL CHIN IMPLANTS

Applicant Hanson Medical, Inc.

K number K973575

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FWP 1997-07-18

DURALASTIC ANATOMICAL CHIN IMPLANTS

Applicant Allied Biomedical Corp.

K number K971478

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FWP 1996-04-19

THE MAGNUM CHIN IMPLANT

Applicant Rand Scientific Corp.

K number K961071

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FWP 1996-03-13

PERMARIDGE HYDROXYLAPATITE MATRIX

Applicant Ceramed Corp.

K number K960349

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FWP 1995-08-21

MEDPOR BARRIER SURGICAL IMPLANT BIOMATERIAL

Applicant Porex Surgical, Inc.

K number K952677

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FWP 1995-03-22

GORE-TEX SAM FACIAL IMPLANT

Applicant W. L. Gore & Associates, Inc.

K number K946267

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FWP 1995-02-07

CHIN IMPLANT STYLE I

Applicant King & Spalding

K number K945998

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FWP 1994-11-18

FLEXIBLE HYDROXYLAPATITE/SILICONE SOFT CHIN IMPLAN

Applicant Microtek Medical, Inc.

K number K925610

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FWP 1994-11-17

THE PERMARIDGE MATRIX CHIN

Applicant Applied Biomaterial Technologies

K number K931500

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FWP 1994-10-18

IMPLANTECH TEMPORAL IMPLANT

Applicant Implantech Associates, Inc.

K number K943644

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FWP 1994-07-28

GORETEX SAM FACIAL IMPLANT

Applicant W. L. Gore & Associates, Inc.

K number K942280

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FWP 1994-07-28

GORE-TEX FACIAL IMPLANT

Applicant W. L. Gore & Associates, Inc.

K number K933367

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FWP 1992-09-02

MEDPOR SURG IMPLANT MATERIAL:PREFOR CRAN/FAC IMPLA

Applicant Porex Technologies Corp.

K number K922489

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FWP 1992-05-06

CHIN WAFER

Applicant Implantech Associates, Inc.

K number K921581

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FWP 1991-12-19

K.D. CHIN IMPLANT

Applicant Implantech Associates, Inc.

K number K914297

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FWP 1991-10-17

3-D ACCUSCAN FACIAL IMPLANTS

Applicant Implantech Associates, Inc.

K number K913761

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FWP 1991-07-01

HIGH PROFILE CHIN IMPLANT

Applicant Implantech Associates, Inc.

K number K911516

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FWP 1991-07-01

ARTICULATED CHIN IMPLANT

Applicant Implantech Associates, Inc.

K number K911514

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FWP 1991-02-19

ZARA SOFT TIP CHIN IMPLANT

Applicant Byron Medical

K number K910458

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FWP 1991-02-19

ZARA EXTENDED CHIN IMPLANT

Applicant Byron Medical

K number K910457

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FWP 1991-02-19

ZARA CHIN IMPLANT

Applicant Byron Medical

K number K910456

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FWP 1991-01-31

FLOWERS JOWL IMPLANT

Applicant Implantech Associates, Inc.

K number K905268

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FWP 1991-01-31

FLOWERS CHIN IMPLANT

Applicant Implantech Associates, Inc.

K number K905267

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FWP 1990-11-26

CUI CURVILINEAR SILICONE CHIN

Applicant Cui Corp.

K number K904349

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FWP 1990-09-12

THE MAGNUM CHIN IMPLANT

Applicant Applied Biomaterial Technologies

K number K902285

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FWP 1990-09-10

CUI ARTICULATED SILICONE CHIN

Applicant Cui Corp.

K number K903327

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FWP 1990-08-02

CURVILINEAR SILICONE CHIN IMPLANT

Applicant Implantech Associates, Inc.

K number K902941

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FWP 1990-08-01

ANATOMICAL MANDIBULAR IMPLANT STYLE II

Applicant Implantech Associates, Inc.

K number K902827

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FWP 1990-08-01

ANATOMICAL MANDIBULAR IMPLANT STYLE I

Applicant Implantech Associates, Inc.

K number K902826

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FWP 1990-08-01

EXTENDED CHIN IMPLANT STYLE II

Applicant Implantech Associates, Inc.

K number K902825

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FWP 1990-08-01

EXTENDED CHIN IMPLANT STYLE I

Applicant Implantech Associates, Inc.

K number K902824

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FWP 1987-05-11

OMEGA SILICONE CHIN IMPLANT

Applicant Omega Silicone, Inc.

K number K871070

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FWP 1987-04-10

ANADIAS ZARA SYSTEM MALAR IMPLANTS

Applicant Anadias, Inc.

K number K871190

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FWP 1987-04-10

OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAR

Applicant Omega Silicone, Inc.

K number K871074

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FWP 1986-10-24

POREX(TM) PROSTHESIS, CHIN, INTERNAL

Applicant Porex Medical

K number K863941

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FWP 1986-09-18

BYRON SILICONE CHIN IMPLANTS

Applicant Byron Medical

K number K863397

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FWP 1984-05-10

MEDPAR SURGICAL IMPLANTS

Applicant Porex Medical

K number K832283

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FWP 1983-11-28

PDM SILOXANE PROSTHETIC CHIN IMPLANT

Applicant Delaware Prosthetics, Inc.

K number K832148

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FWP 1983-08-12

CHIN (MENTOPLASTY) IMPLANTS

Applicant S. Jackson, Inc.

K number K831724

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FWP 1981-09-11

CREAT BRAND WAGNER CHIN IMPLANT

Applicant Aesthetech Corp.

K number K812210

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FWP 1980-05-20

STRAITH CHIN IMPLANTS

Applicant Surgical Technology Laboratories, Inc.

K number K801073

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FWP 1976-11-02

CHIN IMPLANTS

Applicant Mediplast Laboratories, Inc.

K number K760562

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