FDA 510(k) Applications for Medical Device Product Code "GXP"
(Methyl Methacrylate For Cranioplasty)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K011399 | BIOMET, INC. | BIOMET CRANIOFACIAL ACRYLIC CEMENT | 05/05/2003 |
| K990290 | BIOMET, INC. | CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER | 11/18/1999 |
| K043280 | BIOMET, INC. | MIMIX MP BONE VOID FILLER | 12/21/2004 |
| K012569 | BIOMET, INC. | MODIFICATION TO: INJECTABLE MIMIX | 12/21/2001 |
| K040152 | Cardinal Health | BONE CEMENT FOR CRANIOPLASTY | 05/19/2004 |
| K071791 | Codman & Shurtleff, Inc. | MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280 | 07/30/2007 |
| K182742 | Dimensional Bioceramics, LLC | DB-CMF | 06/20/2019 |
| K011736 | DOCTOR'S RESEARCH GROUP, INC. | DRG QUICKMIX | 01/30/2002 |
| K091382 | DOCTORS RESEARCH GROUP, INC. | KRYPTONITE BONE CEMENT | 11/16/2009 |
| K983009 | ETEX CORP. | BSM- BONE SUBSTITUTE MATERIAL | 11/25/1998 |
| K032307 | ETEX CORP. | CAP BONE SUBSTITUTE MATERIAL | 10/24/2003 |
| K023575 | IMMEDICA, INC. | CONCERT CRANIOPLAST | 01/22/2003 |
| K070012 | KYUNGWON MEDICAL CO., LTD. | POLYBONE | 12/27/2007 |
| K973789 | NORIAN CORP. | NORIAN CRANIAL REPAIR SYSTEM (CRS)BONE CEMENT- 5CC KIT, NORIAN CRANIAL REPAIR SYSTEM (CRS) BONE CEMENT- 10CC | 05/18/1998 |
| K232771 | Orthocon, Inc. | Montage Flowable Settable, Resorbable Bone Paste | 02/16/2024 |
| K221933 | Orthocon, Inc. | MONTAGE Settable, Resorbable Bone Putty | 01/13/2023 |
| K231475 | Orthocon, Inc. | MONTAGE-QS Settable, Resorbable Bone Putty | 10/12/2023 |
| K241027 | Orthocon, Inc. | Permatage Settable Bone Putty | 09/26/2024 |
| K953339 | OSTEOGENICS, INC. | BONESOURCE HYDROXYAPATITE CEMENT (HAC) | 06/27/1996 |
| K964537 | OSTEOGENICS, INC. | BONESOURCE HYDROXYAPATITE CEMENT (HAC) | 01/24/1997 |
| K051093 | OSTEOPORE, INC. | OSTEOPORE PCL SCAFFOLD | 03/17/2006 |
| K072601 | OSTEOSYMBIONICS, LLC | OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT | 12/10/2007 |
| K994022 | PARALLAX MEDICAL, INC. | PARALLAX CRANIOSET | 08/31/2000 |
| K982040 | POREX SURGICAL, INC. | MEDPOR SURGICAL GRANULE IMPLANTS | 09/08/1998 |
| K042072 | SKELETAL KINETICS, LLC | CALLOS CMF BONE VOID FILLER | 09/16/2004 |
| K051784 | SKELETAL KINETICS, LLC | OSTEOVATION CMF BONE VOID FILLER | 07/20/2005 |
| K162864 | Skeletal Kinetics, LLC. | OsteoVation Impact | 01/13/2017 |
| K143661 | STRYKER | DirectInject | 09/02/2015 |
| K060763 | Stryker | STRYKER INJECTABLE CEMENT | 09/22/2006 |
| K043334 | STRYKER INSTRUMENTS | BONE SOURCE HAC RAPID SETTING CEMENT | 02/09/2005 |
| K021440 | STRYKER INSTRUMENTS | BONESOURCE HAC | 08/02/2002 |
| K032366 | STRYKER INSTRUMENTS | BONESOURCE HAC FAST SETTING CEMENT | 10/30/2003 |
| K991398 | STRYKER LEIBINGER | BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT | 09/22/1999 |
| K012589 | SYNTHES (USA) | FAST SET PUTTY | 02/07/2002 |
| K060445 | SYNTHES (USA) | NORIAN CRS BONE CEMENT | 04/13/2006 |
| K060443 | SYNTHES (USA) | NORIAN CRS FAST SET PUTTY | 04/13/2006 |
| K041350 | SYNTHES (USA) | SYNTHES (USA) CHRONOS | 07/08/2004 |
| K102018 | SYNTHES USA PRODUCTS LLC | NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY | 09/23/2010 |
| K042414 | TECRES | VISIOPLAST ACRYLIC RESIN | 12/29/2004 |
| K023718 | WALTER LORENZ SURGICAL, INC. | QUICKSET MIMIX BONE VOID FILLER | 12/04/2002 |
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