Product code FWP
- Device name
- Prosthesis, Chin, Internal
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.3550
- Review panel
- SU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254233 | MEDPOR Customized Implant Kit | Stryker Leibinger GmbH & Co KG | 2026-03-12 |
| K232593 | FITme Customized Silicone Implant | Keosan Trading Co. | 2023-11-22 |
| K200610 | Customized Contour Implant | Implantech Associates, Inc. | 2020-12-23 |
| K191130 | Customized Contour Implant | Implantech Associates, Inc. | 2019-08-23 |
| K191916 | Stryker CMF MEDPOR Priority Customized Implant Kit | Stryker Leibinger GmbH & Co KG | 2019-08-15 |
| K153508 | Stryker CMF MEDPOR Customized Implant | Stryker | 2016-02-05 |
| K152463 | SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant | Poriferous, LLC | 2016-01-20 |
| K143173 | Stryker CMF MEDPOR Customized Implant | Stryker | 2015-03-23 |
| K141027 | 3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II IMPLANT, DORSAL COLUMELLA IMP | Implantech Associates, Inc. | 2014-07-10 |
| K121315 | STRYKER CMF MEDPOR CUSTOMIZED IMPLANT | Howmedica Osteonics Corp. | 2012-11-01 |
| K091011 | PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER) | Surgical Technology Laboratories, Inc ("Stl") | 2009-04-22 |
| K021417 | AART CHIN IMPLANT | Aesthetic and Reconstructive Technologies, Inc. | 2002-07-02 |
| K012350 | MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL | Porex Surgical, Inc. | 2002-03-14 |
| K992239 | PILLAR CHIN IMPLANT | Pillar Surgical, Inc. | 1999-11-22 |
| K983754 | STANDARD CHIN | Surgical Technology Laboratories, Inc. | 1998-11-20 |
| K982752 | SEARE BIOMEDICAL CHIN IMPLANTS | Seare Biomedical Corp. | 1998-09-30 |
| K981850 | SILIMED CHIN IMPLANTS | Silimed, LLC | 1998-07-09 |
| K980463 | SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT | Spectrum Designs, Inc. | 1998-05-06 |
| K980462 | SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANT | Spectrum Designs, Inc. | 1998-05-06 |
| K980446 | SPECTRUM DESIGNS ANTERIOR CHIN IMPLANT | Spectrum Designs, Inc. | 1998-05-06 |
| K980445 | SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT | Spectrum Designs, Inc. | 1998-05-06 |
| K980444 | SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT | Spectrum Designs, Inc. | 1998-05-06 |
| K980138 | SPECTRUM DESIGNS SYMMETRICAL CHIN IMPLANT | Spectrum Designs, Inc. | 1998-04-03 |
| K980461 | SPECTRUM DESIGNS CLEFT CHIN IMPLANT | Spectrum Designs, Inc. | 1998-03-04 |
| K973575 | DURALASTIC ANATOMICAL CHIN IMPLANTS | Hanson Medical, Inc. | 1997-11-07 |
| K971478 | DURALASTIC ANATOMICAL CHIN IMPLANTS | Allied Biomedical Corp. | 1997-07-18 |
| K961071 | THE MAGNUM CHIN IMPLANT | Rand Scientific Corp. | 1996-04-19 |
| K960349 | PERMARIDGE HYDROXYLAPATITE MATRIX | Ceramed Corp. | 1996-03-13 |
| K952677 | MEDPOR BARRIER SURGICAL IMPLANT BIOMATERIAL | Porex Surgical, Inc. | 1995-08-21 |
| K946267 | GORE-TEX SAM FACIAL IMPLANT | W. L. Gore & Associates, Inc. | 1995-03-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613327300536 | MEDPOR | Stryker Leibinger GmbH & Co. KG | 2023-02-13 |
| 07613327300413 | MEDPOR | Stryker Leibinger GmbH & Co. KG | 2023-01-09 |
| 07613327300437 | MEDPOR | Stryker Leibinger GmbH & Co. KG | 2023-01-09 |
| 07613327300444 | MEDPOR | Stryker Leibinger GmbH & Co. KG | 2023-01-09 |
| 07613327300451 | MEDPOR | Stryker Leibinger GmbH & Co. KG | 2023-01-09 |
| 07613327300475 | MEDPOR | Stryker Leibinger GmbH & Co. KG | 2023-01-09 |
| 07613327300499 | MEDPOR | Stryker Leibinger GmbH & Co. KG | 2023-01-09 |
| 07613327300505 | MEDPOR | Stryker Leibinger GmbH & Co. KG | 2023-01-09 |
| 07613327300512 | MEDPOR | Stryker Leibinger GmbH & Co. KG | 2023-01-09 |
| 07613327300529 | MEDPOR | Stryker Leibinger GmbH & Co. KG | 2023-01-09 |
| 07613327300550 | MEDPOR | Stryker Leibinger GmbH & Co. KG | 2023-01-09 |
| 07613327300567 | MEDPOR | Stryker Leibinger GmbH & Co. KG | 2023-01-09 |
| 07613327300406 | MEDPOR | Stryker Leibinger GmbH & Co. KG | 2023-01-09 |
| M724ACSIZNS1 | Anatomical Chin Sizers | IMPLANTECH ASSOCIATES, INC. | 2017-10-17 |
| M724CEACSIZNS1 | Conform™ Extended Anatomical | IMPLANTECH ASSOCIATES, INC. | 2017-10-17 |
| M724ACMNS1 | Anatomical Chin | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M724ACSNS1 | Anatomical Chin | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M724ACXLNS1 | Anatomical Chin | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M724CEACLNS1 | Conform™ Extended Anatomical Chin | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M724CEACMNS1 | Conform™ Extended Anatomical Chin | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M724ACLNS1 | Anatomical Chin | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M724CEACSNS1 | Conform™ Extended Anatomical Chin | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M724CEACXLNS1 | Conform™ Extended Anatomical Chin | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M724CH111NS1 | Chin Implant | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M724CH112NS1 | Chin Implant | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M724CH113NS1 | Chin Implant | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M724CH1141 | Chin Implant | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M724CH114NS1 | Chin Implant | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M724CH115NS1 | Chin Implant | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M724CH11FNS1 | Chin Implant | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |