GXP

BONESOURCE HYDROXYAPATITE CEMENT (HAC)

Advisory panel: Neurology
Total cleared: 43

Recent clearances under product code GXP

K253732 — Permatage Flowable, Settable Bone Paste Orthocon, Inc. · 2026-03-13
K253854 — MONTAGE XT Cranial Cement Orthocon, Inc. · 2026-01-02
K241027 — Permatage Settable Bone Putty Orthocon, Inc. · 2024-09-26
K232771 — Montage Flowable Settable, Resorbable Bone Paste Orthocon, Inc. · 2024-02-16
K231475 — MONTAGE-QS Settable, Resorbable Bone Putty Orthocon, Inc. · 2023-10-12
K221933 — MONTAGE Settable, Resorbable Bone Putty Orthocon, Inc. · 2023-01-13
K182742 — DB-CMF Dimensional Bioceramics, LLC · 2019-06-20
K162864 — OsteoVation Impact Skeletal Kinetics, LLC · 2017-01-13
K143661 — DirectInject Stryker · 2015-09-02
K102018 — NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY Synthes USA Products, LLC · 2010-09-23
K091382 — KRYPTONITE BONE CEMENT Doctors Research Group, Inc. · 2009-11-16
K070012 — POLYBONE Kyung Won Medical Co., Ltd. · 2007-12-27
K072601 — OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT Osteosymbionics, LLC · 2007-12-10
K071791 — MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280 Codman & Shurtleff, Inc. · 2007-07-30
K060763 — STRYKER INJECTABLE CEMENT Stryker · 2006-09-22
K060443 — NORIAN CRS FAST SET PUTTY Synthes (Usa) · 2006-04-13
K060445 — NORIAN CRS BONE CEMENT Synthes (Usa) · 2006-04-13
K051093 — OSTEOPORE PCL SCAFFOLD Osteopore, Inc. · 2006-03-17
K051784 — OSTEOVATION CMF BONE VOID FILLER Skeletal Kinetics, LLC · 2005-07-20
K043334 — BONE SOURCE HAC RAPID SETTING CEMENT Stryker Instruments · 2005-02-09
K042414 — VISIOPLAST ACRYLIC RESIN Tecres · 2004-12-29
K043280 — MIMIX MP BONE VOID FILLER Biomet, Inc. · 2004-12-21
K042072 — CALLOS CMF BONE VOID FILLER Skeletal Kinetics, LLC · 2004-09-16
K041350 — SYNTHES (USA) CHRONOS Synthes (Usa) · 2004-07-08
K040152 — BONE CEMENT FOR CRANIOPLASTY Cardinalhealth · 2004-05-19
K032366 — BONESOURCE HAC FAST SETTING CEMENT Stryker Instruments · 2003-10-30
K032307 — CAP BONE SUBSTITUTE MATERIAL Etex Corp. · 2003-10-24
K011399 — BIOMET CRANIOFACIAL ACRYLIC CEMENT Biomet, Inc. · 2003-05-05
K023575 — CONCERT CRANIOPLAST Immedica, Inc. · 2003-01-22
K023718 — QUICKSET MIMIX BONE VOID FILLER Walter Lorenz Surgical, Inc. · 2002-12-04
K021440 — BONESOURCE HAC Stryker Instruments · 2002-08-02
K012589 — FAST SET PUTTY Synthes (Usa) · 2002-02-07
K011736 — DRG QUICKMIX Doctor'S Research Group, Inc. · 2002-01-30
K012569 — MODIFICATION TO: INJECTABLE MIMIX Biomet, Inc. · 2001-12-21
K994022 — PARALLAX CRANIOSET Parallax Medical, Inc. · 2000-08-31
K990290 — CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER Biomet, Inc. · 1999-11-18
K991398 — BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT Stryker Leibinger · 1999-09-22
K983009 — BSM- BONE SUBSTITUTE MATERIAL Etex Corp. · 1998-11-25
K982040 — MEDPOR SURGICAL GRANULE IMPLANTS Porex Surgical, Inc. · 1998-09-08
K973789 — NORIAN CRANIAL REPAIR SYSTEM (CRS)BONE CEMENT- 5CC KIT, NORIAN CRANIAL REPAIR SYSTEM (CRS) BONE CEMENT- 10CC Norian Corp. · 1998-05-18
K964537 — BONESOURCE HYDROXYAPATITE CEMENT (HAC) Osteogenics, Inc. · 1997-01-24
K953339 — BONESOURCE HYDROXYAPATITE CEMENT (HAC) Osteogenics, Inc. · 1996-06-27
K873689 — CRANIOPLASTIC, ACRYLIC CRANIOPLASTY MATERIAL Dentsply Intl. · 1987-10-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.