FWP

Product Code: FWP


Products Classified as FWP

5547Prosthesis, Chin, InternalChin Prosthesis.

Total Product Life Cycle (TPLC) Devices

5547Prosthesis, Chin, InternalChin Prosthesis.

FDA Consensus Standards

Prosthesis, Chin, Internal [33049]21 CFR §878.3550 🔎
Prosthesis, Chin, Internal [38209]21 CFR §878.3550 🔎

Pre-market Notifications for FWP

K200610Customized Contour ImplantImplantech Associates Inc.
K191916Stryker CMF MEDPOR Priority Customized Implant KitStryker Leibinger GmbH & Co. KG
K191130Customized Contour ImplantImplantech Associates Inc.
K153508Stryker CMF MEDPOR Customized ImplantStryker
K152463SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial ImplantPORIFEROUS LLC
K143173Stryker CMF MEDPOR Customized ImplantStryker
K1410273D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II IMPLANT, DORSAL COLUMELLA IMPIMPLANTECH ASSOCIATES INC.
K121315STRYKER CMF MEDPOR CUSTOMIZED IMPLANTHOWMEDICA OSTEONICS CORP.
K091011PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER)SURGICAL TECHNOLOGY LABORATORIES, INC ("STL")
K021417AART CHIN IMPLANTAESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC.
K012350MEDPOR PLUS SURGICAL IMPLANT BIOMATERIALPOREX SURGICAL, INC.
K992239PILLAR CHIN IMPLANTPILLAR SURGICAL, INC.
K983754STANDARD CHINSURGICAL TECHNOLOGY LABORATORIES, INC.
K982752SEARE BIOMEDICAL CHIN IMPLANTSSEARE BIOMEDICAL CORP.
K981850SILIMED CHIN IMPLANTSSILIMED, LLC.

Global Unique Device Identification Database

00813845020092PROSTHESIS, CHIN, INTERNAL
00813845020061PROSTHESIS, CHIN, INTERNAL
00813845020054PROSTHESIS, CHIN, INTERNAL
00812790023288Prosthesis, Chin, Internal
00812790023271Prosthesis, Chin, Internal
00812790023264Prosthesis, Chin, Internal
00812790023257Prosthesis, Chin, Internal
00812790023240Prosthesis, Chin, Internal
00812790023233Prosthesis, Chin, Internal
00812790023226Prosthesis, Chin, Internal
00812790023219Prosthesis, Chin, Internal
00815285021790Prosthesis, Chin, Internal
00815285021783Prosthesis, Chin, Internal
00815285021776Prosthesis, Chin, Internal
00815285021769Prosthesis, Chin, Internal

Maude Adverse Events

UNKNOWN_FRO_PRODUCTSTRYKER ORTHOBIOLOGICS-MALVERN2020-03-06
CONFORM MANDIBULAR ANGLE(TM)IMPLANTECH ASSOCIATE, INC.2020-02-25
HTR-PMI BUCKLEY RIGHT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANTBIOMET MICROFIXATION2020-02-10
MEDPOR CUSTOMIZED CRANIAL-LSTRYKER ORTHOBIOLOGICS-MALVERN2019-11-26
UNKNOWN_FRO_PRODUCTSTRYKER ORTHOBIOLOGICS-MALVERN2019-11-22
UNKNOWN_FRO_PRODUCTSTRYKER ORTHOBIOLOGICS-MALVERN2019-10-24
UNKNOWN_FRO_PRODUCTSTRYKER ORTHOBIOLOGICS-MALVERN2019-10-22
BUTTON CHIN - SMALL - 40MM X 25MM X 4MMSTRYKER ORTHOBIOLOGICS-MALVERN2019-08-15
3D ACCUSCAN IMPLANTSIMPLANTECH ASSOCIATES INC.2019-08-01
UNKNOWN_FRO_PRODUCTSTRYKER ORTHOBIOLOGICS-MALVERN2019-07-16
TRANSSPHENOIDAL SELLAR IMPLANTSTRYKER ORTHOBIOLOGICS-MALVERN2019-06-05
TRANSSPHENOIDAL SELLAR IMPLANTSTRYKER ORTHOBIOLOGICS-MALVERN2019-05-31
TRANSSPHENOIDAL SELLAR IMPLANTSTRYKER ORTHOBIOLOGICS-MALVERN2019-05-31
TRANSSPHENOIDAL SELLAR IMPLANTSTRYKER ORTHOBIOLOGICS-MALVERN2019-05-31
LARGE PARANASAL - RIGHT - 30MM X 28MMSTRYKER ORTHOBIOLOGICS-MALVERN2019-03-01
WIDENING MANDIBULAR ANGLE(TM)IMPLANTECH ASSOCIATES, INC.2019-01-23
UNKNOWN_FRO_PRODUCTSTRYKER ORTHOBIOLOGICS-MALVERN2018-11-13
UNKNOWN_FRO_PRODUCTSTRYKER ORTHOBIOLOGICS-MALVERN2018-11-13
UNKNOWN_FRO_PRODUCTSTRYKER ORTHOBIOLOGICS-MALVERN2018-11-13
MEDPOR CUSTOMIZED-PLUS-LSTRYKER ORTHOBIOLOGICS-MALVERN2018-08-30
MITTELMAN(R) PRE JOWL CHIN (TM), EXTRA LARGEIMPLANTECH ASSOCIATES, INC.2018-05-23
CONFORM (TM) EXTENDED ANATOMICAL CHINIMPLANTECH ASSOCIATES, INC.2018-04-19
MEDPOR BLOCK 38MM X 63MM X 9.5STRYKER ORTHOBIOLOGICS-MALVERN2018-02-16
SST EZ SPHERE - 22MMSTRYKER ORTHOBIOLOGICS-MALVERN2017-11-01
SST EZ SPHERE - 22MMSTRYKER LEIBINGER FREIBURG2017-11-01
SST EZ SPHERE - 22MMSTRYKER ORTHOBIOLOGICS-MALVERN2017-10-31
SST EZ SPHERE - 22MMSTRYKER ORTHOBIOLOGICS-MALVERN2017-10-31
UNKNOWN_FRO_PRODUCTSTRYKER LEIBINGER FREIBURG2017-10-19
MANDIBLE ANGLE - RIGHT - 47MMSTRYKER ORTHOBIOLOGICS-MALVERN2017-08-02
MANDIBLE ANGLE - LEFT - 47MM XSTRYKER ORTHOBIOLOGICS-MALVERN2017-08-02
SST EZ SPHERE - 22MMSTRYKER ORTHOBIOLOGICS-MALVERN2017-05-25
MEDPOR CUSTOMIZED CRANIAL-LSTRYKER ORTHOBIOLOGICS-MALVERN2017-04-24
MEDPOR CUSTOMIZED CRANIAL-LSTRYKER LEIBINGER FREIBURG2017-03-03
MEDPOR CUSTOMIZED CRANIAL-LSTRYKER LEIBINGER FREIBURG2017-02-28
MEDPOR CUSTOMIZED CRANIAL-XLSTRYKER ORTHOBIOLOGICS-MALVERN2017-02-24
MEDPOR CUSTOMIZED CRANIAL-XLSTRYKER ORTHOBIOLOGICS-MALVERN2017-02-24
BARRIER RECTANGLE - 50MM X 76MSTRYKER LEIBINGER FREIBURG2016-12-29
MEDPOR CUSTOMIZED CRANIAL-XLSTRYKER ORTHOBIOLOGICS-MALVERN2016-08-30
MEDPOR CUSTOMIZED CRANIAL-XLSTRYKER ORTHOBIOLOGICS-MALVERN2016-07-12
UNKNOWN_FRO_PRODUCTSTRYKER ORTHOBIOLOGICS-MALVERN2016-06-13
UNKNOWN_FRO_PRODUCTSTRYKER LEIBINGER FREIBURG2016-03-28
ENOPTHALMOS WEDGE - REGULARSTRYKER ORTHOBIOLOGICS-MALVERN2016-03-21
INFERIOR 2/3 ORBIT - LEFT - 10STRYKER ORTHOBIOLOGICS-MALVERN2015-12-04
MEDPOR CUSTOMIZED AUGMENTATIONSTRYKER ORTHOBIOLOGICS-MALVERN2015-09-04
UNKNOWNIMPLANTECH ASSOCIATES INC.2015-09-01
CONTOURED MANDIBULAR ANGLE - LSTRYKER ORTHOBIOLOGICS-MALVERN2015-08-14
CONTOURED MANDIBULAR ANGLE - LSTRYKER ORTHOBIOLOGICS - MALVERN2015-08-13
NASAL DARTT IMPLANT - 40M X 4MSTRYKER ORTHOBIOLOGICS-MALVERN2015-04-22
MEDPOR CUSTOMIZED MIDFACESTRYKER ORTHOBIOLOGICS-MALVERN2015-02-20
CONFORM (TM) EXTENDED ANATOMICAL CHINIMPLANTECH ASSOCIATES, INC.2015-01-09
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