Methyl Methacrylate For Cranioplasty

FDA product code GXP · 44 cleared devices

Class 2 Neurology

Regulation: 21 CFR 882.5300
Review panel: NE
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1987-10-26 – 2026-07-30

GXP 2026-07-30

TnR Cranial Implant

Applicant T&R BIOFAB CO., Ltd.

K number K251959

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GXP 2026-06-15

Permatage XT Settable Bone Putty

Applicant Orthocon, Inc.

K number K261265

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GXP 2026-03-13

Permatage Flowable, Settable Bone Paste

Applicant Orthocon, Inc.

K number K253732

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GXP 2026-01-02

MONTAGE XT Cranial Cement

Applicant Orthocon, Inc.

K number K253854

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GXP 2024-09-26

Permatage Settable Bone Putty

Applicant Orthocon, Inc.

K number K241027

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GXP 2024-02-16

Montage Flowable Settable, Resorbable Bone Paste

Applicant Orthocon, Inc.

K number K232771

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GXP 2023-10-12

MONTAGE-QS Settable, Resorbable Bone Putty

Applicant Orthocon, Inc.

K number K231475

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GXP 2023-01-13

MONTAGE Settable, Resorbable Bone Putty

Applicant Orthocon, Inc.

K number K221933

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GXP 2019-06-20

DB-CMF

Applicant Dimensional Bioceramics, LLC

K number K182742

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GXP 2017-01-13

OsteoVation Impact

Applicant Skeletal Kinetics, LLC

K number K162864

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GXP 2010-09-23

NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY

Applicant Synthes USA Products, LLC

K number K102018

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GXP 2009-11-16

KRYPTONITE BONE CEMENT

Applicant Doctors Research Group, Inc.

K number K091382

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GXP 2007-12-27

POLYBONE

Applicant Kyung Won Medical Co., Ltd.

K number K070012

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GXP 2007-12-10

OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT

Applicant Osteosymbionics, LLC

K number K072601

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GXP 2007-07-30

MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280

Applicant Codman & Shurtleff, Inc.

K number K071791

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GXP 2006-09-22

STRYKER INJECTABLE CEMENT

Applicant Stryker

K number K060763

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GXP 2006-04-13

NORIAN CRS BONE CEMENT

Applicant Synthes (Usa)

K number K060445

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GXP 2006-04-13

NORIAN CRS FAST SET PUTTY

Applicant Synthes (Usa)

K number K060443

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GXP 2006-03-17

OSTEOPORE PCL SCAFFOLD

Applicant Osteopore, Inc.

K number K051093

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GXP 2005-07-20

OSTEOVATION CMF BONE VOID FILLER

Applicant Skeletal Kinetics, LLC

K number K051784

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GXP 2005-02-09

BONE SOURCE HAC RAPID SETTING CEMENT

Applicant Stryker Instruments

K number K043334

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GXP 2004-12-29

VISIOPLAST ACRYLIC RESIN

Applicant Tecres

K number K042414

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GXP 2004-12-21

MIMIX MP BONE VOID FILLER

Applicant Biomet, Inc.

K number K043280

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GXP 2004-09-16

CALLOS CMF BONE VOID FILLER

Applicant Skeletal Kinetics, LLC

K number K042072

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GXP 2004-07-08

SYNTHES (USA) CHRONOS

Applicant Synthes (Usa)

K number K041350

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GXP 2004-05-19

BONE CEMENT FOR CRANIOPLASTY

Applicant Cardinalhealth

K number K040152

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GXP 2003-10-30

BONESOURCE HAC FAST SETTING CEMENT

Applicant Stryker Instruments

K number K032366

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GXP 2003-10-24

CAP BONE SUBSTITUTE MATERIAL

Applicant Etex Corp.

K number K032307

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GXP 2003-05-05

BIOMET CRANIOFACIAL ACRYLIC CEMENT

Applicant Biomet, Inc.

K number K011399

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GXP 2003-01-22

CONCERT CRANIOPLAST

Applicant Immedica, Inc.

K number K023575

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GXP 2002-12-04

QUICKSET MIMIX BONE VOID FILLER

Applicant Walter Lorenz Surgical, Inc.

K number K023718

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GXP 2002-08-02

BONESOURCE HAC

Applicant Stryker Instruments

K number K021440

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GXP 2002-02-07

FAST SET PUTTY

Applicant Synthes (Usa)

K number K012589

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GXP 2002-01-30

DRG QUICKMIX

Applicant Doctor'S Research Group, Inc.

K number K011736

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GXP 2001-12-21

MODIFICATION TO: INJECTABLE MIMIX

Applicant Biomet, Inc.

K number K012569

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GXP 2000-08-31

PARALLAX CRANIOSET

Applicant Parallax Medical, Inc.

K number K994022

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GXP 1999-11-18

CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER

Applicant Biomet, Inc.

K number K990290

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GXP 1999-09-22

BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT

Applicant Stryker Leibinger

K number K991398

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GXP 1998-11-25

BSM- BONE SUBSTITUTE MATERIAL

Applicant Etex Corp.

K number K983009

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GXP 1998-09-08

MEDPOR SURGICAL GRANULE IMPLANTS

Applicant Porex Surgical, Inc.

K number K982040

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GXP 1998-05-18

NORIAN CRANIAL REPAIR SYSTEM (CRS)BONE CEMENT- 5CC KIT, NORIAN CRANIAL REPAIR SYSTEM (CRS) BONE CEMENT- 10CC

Applicant Norian Corp.

K number K973789

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GXP 1997-01-24

BONESOURCE HYDROXYAPATITE CEMENT (HAC)

Applicant Osteogenics, Inc.

K number K964537

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GXP 1996-06-27

BONESOURCE HYDROXYAPATITE CEMENT (HAC)

Applicant Osteogenics, Inc.

K number K953339

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GXP 1987-10-26

CRANIOPLASTIC, ACRYLIC CRANIOPLASTY MATERIAL

Applicant Dentsply Intl.

K number K873689

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