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 |
K221933 |
Orthocon, Inc. |
MONTAGE Settable, Resorbable Bone Putty |
01/13/2023 |
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 |