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510(k) K191916

Device
Stryker CMF MEDPOR Priority Customized Implant Kit
Applicant
Stryker Leibinger GmbH & Co. KG
510(k) number
K191916
Product code
FWP  
Decision
Substantially Equivalent (SESE)
Decision date
2019-08-15
Date received
2019-07-17
Regulation
878.3550
Classification name
Prosthesis, Chin, Internal
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Gregory Gohl
Address
Boetzinger Strasse 41 D-79111 Freiburg DE

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FWP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K254233MEDPOR Customized Implant KitStryker Leibinger GmbH & Co KG2026-03-12
K232593FITme Customized Silicone ImplantKeosan Trading Co.2023-11-22
K200610Customized Contour ImplantImplantech Associates, Inc.2020-12-23
K191130Customized Contour ImplantImplantech Associates, Inc.2019-08-23
K153508Stryker CMF MEDPOR Customized ImplantStryker2016-02-05
K152463SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial ImplantPoriferous, LLC2016-01-20
K143173Stryker CMF MEDPOR Customized ImplantStryker2015-03-23
K1410273D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II IMPLANT, DORSAL COLUMELLA IMPImplantech Associates, Inc.2014-07-10
K121315STRYKER CMF MEDPOR CUSTOMIZED IMPLANTHowmedica Osteonics Corp.2012-11-01
K091011PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER)Surgical Technology Laboratories, Inc ("Stl")2009-04-22
K021417AART CHIN IMPLANTAesthetic and Reconstructive Technologies, Inc.2002-07-02
K012350MEDPOR PLUS SURGICAL IMPLANT BIOMATERIALPorex Surgical, Inc.2002-03-14
K992239PILLAR CHIN IMPLANTPillar Surgical, Inc.1999-11-22
K983754STANDARD CHINSurgical Technology Laboratories, Inc.1998-11-20
K982752SEARE BIOMEDICAL CHIN IMPLANTSSeare Biomedical Corp.1998-09-30

Legacy Summary#

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FDA Review#

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