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Panels › Neurology › Product code GXP · Class 2

Methyl Methacrylate For Cranioplasty

Regulation 882.5300

4510(k)s in 12 months (45 all time)
0recalls in 12 months (30 all time)
30recalls that name a 510(k)
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Top companies in GXP

Company510(k)sRecalls
Skeletal Kinetics, LLC325
Orthocon, Inc.70
Biomet, Inc.40
Synthes (Usa)40
Stryker Instruments30
Doctor'S Research Group, Inc.11
Etex Corp.20
Osteogenics, Inc.20
Stryker20
Stryker Leibinger11
Decided510(k)Device and applicantCode
Jul 30, 2026K251959TnR Cranial Implant
T&R BIOFAB CO., Ltd., KR
GXP
Jun 15, 2026K261265Permatage XT Settable Bone Putty
Orthocon, Inc.
GXP
Mar 13, 2026K253732Permatage Flowable, Settable Bone Paste
Orthocon, Inc.
GXP
Jan 2, 2026K253854MONTAGE XT Cranial Cement
Orthocon, Inc.
GXP
Sep 26, 2024K241027Permatage Settable Bone Putty
Orthocon, Inc.
GXP
Feb 16, 2024K232771Montage Flowable Settable, Resorbable Bone Paste
Orthocon, Inc.
GXP
Oct 12, 2023K231475MONTAGE-QS Settable, Resorbable Bone Putty
Orthocon, Inc.
GXP
Jan 13, 2023K221933MONTAGE Settable, Resorbable Bone Putty
Orthocon, Inc.
GXP
Jun 20, 2019K182742DB-CMF
Dimensional Bioceramics, LLC
GXP
Jan 13, 2017K162864OsteoVation Impact
Skeletal Kinetics, LLC
GXP
Sep 2, 2015K143661DirectInject
Stryker
GXP
Sep 23, 2010K102018NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY
Synthes USA Products, LLC
GXP
Nov 16, 2009K091382KRYPTONITE BONE CEMENT
Doctors Research Group, Inc.
GXP
Dec 27, 2007K070012POLYBONE
Kyung Won Medical Co., Ltd.
GXP
Dec 10, 2007K072601OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT
Osteosymbionics, LLC
GXP
Jul 30, 2007K071791MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280
Codman & Shurtleff, Inc.
GXP
Sep 22, 2006K060763STRYKER INJECTABLE CEMENT
Stryker
GXP
Apr 13, 2006K060445NORIAN CRS BONE CEMENT
Synthes (Usa)
GXP
Apr 13, 2006K060443NORIAN CRS FAST SET PUTTY
Synthes (Usa)
GXP
Mar 17, 2006K051093OSTEOPORE PCL SCAFFOLD
Osteopore, Inc.
GXP
Jul 20, 2005K051784OSTEOVATION CMF BONE VOID FILLER
Skeletal Kinetics, LLC
GXP
Feb 9, 2005K043334BONE SOURCE HAC RAPID SETTING CEMENT
Stryker Instruments
GXP
Dec 29, 2004K042414VISIOPLAST ACRYLIC RESIN
Tecres
GXP
Dec 21, 2004K043280MIMIX MP BONE VOID FILLER
Biomet, Inc.
GXP
Sep 16, 2004K042072CALLOS CMF BONE VOID FILLER
Skeletal Kinetics, LLC
GXP
Jul 8, 2004K041350SYNTHES (USA) CHRONOS
Synthes (Usa)
GXP
May 19, 2004K040152BONE CEMENT FOR CRANIOPLASTY
Cardinalhealth
GXP
Oct 30, 2003K032366BONESOURCE HAC FAST SETTING CEMENT
Stryker Instruments
GXP
Oct 24, 2003K032307CAP BONE SUBSTITUTE MATERIAL
Etex Corp.
GXP
May 5, 2003K011399BIOMET CRANIOFACIAL ACRYLIC CEMENT
Biomet, Inc.
GXP
Jan 22, 2003K023575CONCERT CRANIOPLAST
Immedica, Inc.
GXP
Dec 4, 2002K023718QUICKSET MIMIX BONE VOID FILLER
Walter Lorenz Surgical, Inc.
GXP
Aug 2, 2002K021440BONESOURCE HAC
Stryker Instruments
GXP
Feb 7, 2002K012589FAST SET PUTTY
Synthes (Usa)
GXP
Jan 30, 2002K011736DRG QUICKMIX
Doctor'S Research Group, Inc.
GXP
Dec 21, 2001K012569MODIFICATION TO: INJECTABLE MIMIX
Biomet, Inc.
GXP
Aug 31, 2000K994022PARALLAX CRANIOSET
Parallax Medical, Inc.
GXP
Nov 18, 1999K990290CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER
Biomet, Inc.
GXP
Sep 22, 1999K991398BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT
Stryker Leibinger
GXP
Nov 25, 1998K983009BSM- BONE SUBSTITUTE MATERIAL
Etex Corp.
GXP
Sep 8, 1998K982040MEDPOR SURGICAL GRANULE IMPLANTS
Porex Surgical, Inc.
GXP
May 18, 1998K973789NORIAN CRANIAL REPAIR SYSTEM (CRS)BONE CEMENT- 5CC KIT, NORIAN CRANIAL REPAIR SYSTEM (CRS) BONE CEMENT- 10CC
Norian Corp.
GXP
Jan 24, 1997K964537BONESOURCE HYDROXYAPATITE CEMENT (HAC)
Osteogenics, Inc.
GXP
Jun 27, 1996K953339BONESOURCE HYDROXYAPATITE CEMENT (HAC)
Osteogenics, Inc.
GXP
Oct 26, 1987K873689CRANIOPLASTIC, ACRYLIC CRANIOPLASTY MATERIAL
Dentsply Intl.
GXP

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