FDA.report

510(k) K254233

Device
MEDPOR Customized Implant Kit
Applicant
Stryker Leibinger GmbH & Co KG
510(k) number
K254233
Product code
FWP
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-12
Date received
2025-12-29
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
N

Related Records

Applicant Contact

Contact
Stephani Herbert
Address
Botzinger Strasse 41 Frieburg DE 79111 79111

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code FWP

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K191130Customized Contour ImplantImplantech Associates, Inc.2019-08-23
K191916Stryker CMF MEDPOR Priority Customized Implant KitStryker Leibinger GmbH & Co KG2019-08-15
K153508Stryker CMF MEDPOR Customized ImplantStryker2016-02-05
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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