FDA.report

510(k) K253854

Device
MONTAGE XT Cranial Cement
Applicant
Orthocon, Inc.
510(k) number
K253854
Product code
GXP
Decision
Substantially Equivalent (SESE)
Decision date
2026-01-02
Date received
2025-12-03
Regulation
882.5300
Classification name
Methyl Methacrylate For Cranioplasty
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Alyssa McDermott
Address
700 Fairfield Ave. Suite 1 Stamford CT US 06902 06902

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code GXP

510(k)DeviceApplicantDecision date
K253732Permatage Flowable, Settable Bone PasteOrthocon, Inc.2026-03-13
K241027Permatage Settable Bone PuttyOrthocon, Inc.2024-09-26
K232771Montage Flowable Settable, Resorbable Bone PasteOrthocon, Inc.2024-02-16
K231475MONTAGE-QS Settable, Resorbable Bone PuttyOrthocon, Inc.2023-10-12
K221933MONTAGE Settable, Resorbable Bone PuttyOrthocon, Inc.2023-01-13
K182742DB-CMFDimensional Bioceramics, LLC2019-06-20
K162864OsteoVation ImpactSkeletal Kinetics, LLC2017-01-13
K143661DirectInjectStryker2015-09-02
K102018NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTYSynthes USA Products, LLC2010-09-23
K091382KRYPTONITE BONE CEMENTDoctors Research Group, Inc.2009-11-16
K070012POLYBONEKyung Won Medical Co., Ltd.2007-12-27
K072601OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANTOsteosymbionics, LLC2007-12-10
K071791MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280Codman & Shurtleff, Inc.2007-07-30
K060763STRYKER INJECTABLE CEMENTStryker2006-09-22
K060443NORIAN CRS FAST SET PUTTYSynthes (Usa)2006-04-13