Filler, Bone Void, Calcium Compound

FDA product code MQV · 455 cleared devices

Class 2 Orthopedic

Regulation: 21 CFR 888.3045
Review panel: OR
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1996-06-21 – 2026-09-11

MQV 2010-11-09

INTERFACE

Applicant Biostructures

K number K092541

View details →

MQV 2010-10-27

FM-02 BONE GRAFT SUBSTITUTE

Applicant Orthovita, Inc.

K number K102545

View details →

MQV 2010-09-01

NOVABONE PUTTY- BIOACTIVE SYNTHETIC BONE GRAFT

Applicant Novabone Products, LLC

K number K101860

View details →

MQV 2010-08-19

BONEOPTIMIZER

Applicant Curasan AG

K number K100841

View details →

MQV 2010-07-29

BIOGENNIX RPC

Applicant Biogennix, LLC

K number K093342

View details →

MQV 2010-07-20

CALLOS BONE VOID FILLER, SKAFFOLD NEXT GENERATION BONE VOID FILLER, OSTEO VATION

Applicant Skeletal Kinetics, LLC

K number K100986

View details →

MQV 2010-07-01

GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN

Applicant Etex Corp.

K number K101557

View details →

MQV 2010-06-23

B-GENIN AND R-GENIN

Applicant Berkeley Advanced Biomaterials, Inc.

K number K091912

View details →

MQV 2010-05-28

SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX

Applicant Collagen Matrix, Inc.

K number K092608

View details →

MQV 2010-04-22

NANOSS BONE VOID FILLER

Applicant Pioneer Surgical Technology

K number K100361

View details →

MQV 2010-04-22

GRAFTY QUICKSET

Applicant Graftys

K number K093343

View details →

MQV 2010-03-24

BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY

Applicant Berkeley Advanced Biomaterials, Inc.

K number K092046

View details →

MQV 2010-03-02

A-GRIX RESORBABLE BONE VOID FILLER

Applicant Ag Digital Technology Corp.

K number K091688

View details →

MQV 2010-02-18

CARRIGEN

Applicant Etex Corp.

K number K093447

View details →

MQV 2010-01-08

ORTHOSS

Applicant Ed. Geistlich Soehne AG Fur Chemische Industrie

K number K090401

View details →

MQV 2009-12-04

INTEGRA MOZAIK AND OS MOLDABLE MORSELS

Applicant Integra LifeSciences Corporation

K number K091302

View details →

MQV 2009-12-01

DUOWEDGE SYNTHETIC BONE SUBSTITUTE

Applicant Kasios

K number K073214

View details →

MQV 2009-11-17

PIONEER SURGICAL NANOSS BVF-E

Applicant Pioneer Surgical Technology

K number K091031

View details →

MQV 2009-11-02

ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE

Applicant Etex Corp.

K number K091607

View details →

MQV 2009-10-23

CURIOS

Applicant Progentix Orthobiology BV

K number K090641

View details →

MQV 2009-09-28

DBX DEMINERALIZED BONE MATRIX PUTTY

Applicant Musculoskeletal Transplant Foundation

K number K091218

View details →

MQV 2009-09-28

KAINOS+

Applicant Signus Medizintechnik GmbH

K number K090387

View details →

MQV 2009-09-18

EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTE

Applicant Etex Corp.

K number K090855

View details →

MQV 2009-09-11

OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY

Applicant Bacterin International, Inc.

K number K091321

View details →

MQV 2009-09-04

CERAMENT IBONE VOID FILLER HIGH CONTRAST, MODEL A 0210-12

Applicant Bonesupport AB

K number K090871

View details →

MQV 2009-08-27

WMT COMPOSITE DBM

Applicant Wrightmedicaltechnologyinc

K number K083270

View details →

MQV 2009-06-12

E-MATRIX GRAFT BONE EXTENDER

Applicant Pioneer Surgical Technology

K number K083449

View details →

MQV 2009-06-02

MASTERGRAFT STRIP

Applicant Medtronic Sofamor Danek

K number K082166

View details →

MQV 2009-05-27

REOSS POWDER, REOSS PUTTY, REOSS GEL, MODELS R-1,RP-1, RG-1

Applicant Intra-Lock International, Inc.

K number K082419

View details →

MQV 2009-05-21

OSTEOCRETE BONE VOID FILLER

Applicant Bone Solutions, Inc.

K number K071004

View details →

MQV 2009-04-15

NOVABONE POROUS - SYNTHETIC BONE GRAFT SCAFFOLD

Applicant Novabone Products, LLC

K number K090731

View details →

MQV 2009-04-02

INTERGRO DBM

Applicant Biomet Spine

K number K082793

View details →

MQV 2009-03-24

EQUIVABONE

Applicant Etex Corp.

K number K090310

View details →

MQV 2009-02-25

GRAFTYS HBS

Applicant Graftys

K number K082498

View details →

MQV 2009-02-20

GAMMA-BSM, BETA-BSM

Applicant Etex Corp.

K number K090242

View details →

MQV 2009-02-20

INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE

Applicant Inion OY

K number K090177

View details →

MQV 2009-02-09

MASTERGRAFT RESORBABLE CERAMIC GRANULES

Applicant Medtronic Sofamor Danek

K number K082918

View details →

MQV 2009-01-28

CALTRIX RESORBABLE BONE VOID FILLER

Applicant Ag Digital Technology Corp.

K number K083279

View details →

MQV 2008-12-24

MODIFICATION TO:MICROFUSE BONE VOID FILLER

Applicant Globus Medical, Inc.

K number K083232

View details →

MQV 2008-12-09

NOVABONE PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT

Applicant Novabone Products, LLC

K number K082672

View details →

MQV 2008-12-04

ALLOFUSE GEL AND PUTTY

Applicant Allosource, Inc.

K number K071849

View details →

MQV 2008-11-25

ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTES

Applicant Apatech , Ltd.

K number K082575

View details →

MQV 2008-11-24

PROGENIX PLUS

Applicant Medtronic Sofamor Danek

K number K082002

View details →

MQV 2008-11-14

GENEX

Applicant Biocomposites, Ltd.

K number K082381

View details →

MQV 2008-11-06

VITOSS BONE GRAFT SUBSTITUTE, BONE GRAFT SUBSTITUTE FILLED CANISTER, FOAM & BIOACTIVE FOAM BONE GRAFT SUBSTITUTE

Applicant Orthovita, Inc.

K number K083033

View details →

MQV 2008-11-06

ACTIFUSE BONE GRAFT SUBSTITUTE AND E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTE

Applicant Apatech , Ltd.

K number K081979

View details →

MQV 2008-10-16

GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES

Applicant Osteotech, Inc.

K number K082615

View details →

MQV 2008-10-16

POLYBONE GRANULE & BLOCK

Applicant Kyung Won Medical Co., Ltd.

K number K082338

View details →

MQV 2008-10-10

TRICOS A RESORBABLE BONE SUBSTITUTE

Applicant Baxter Healthcare Corp

K number K081717

View details →

MQV 2008-10-07

MODIFICATION TO MICROFUSE BONE VOID FILLER

Applicant Globus Medical, Inc.

K number K082442

View details →

MQV 2008-09-11

ACTIFUSE FLOW BONE GRAFT SUBSTITUTE

Applicant Apatech , Ltd.

K number K082073

View details →

MQV 2008-09-03

HEALOS FX INJECTABLE BONE GRAFT REPLACEMENT, MODELS 276175002, 276175005, 276175010, 276175015

Applicant Depuy Spine, Inc.

K number K081758

View details →

MQV 2008-08-25

PIONEER SURGICAL TECHNOLOGY NANOSS BVF-E, MODELS 5, 10, 20CC

Applicant Pioneer Surgical Technology

K number K081558

View details →

MQV 2008-07-22

PLEXUR M

Applicant Osteotech, Inc.

K number K081227

View details →

MQV 2008-07-09

GENEX PUTTY

Applicant Biocomposites, Ltd.

K number K073341

View details →

MQV 2008-06-20

CERAMENT BONE VOID FILLER, MODEL A0210

Applicant Bonesupport AB

K number K073316

View details →

MQV 2008-06-17

VITOSS BIOACTIVE FOAM PACK BONE GRAFT SUBSTITUTE

Applicant Orthovita, Inc.

K number K081439

View details →

MQV 2008-05-06

NOVABONE PUTTY- BIOACTIVE SYNTHETIC GRAFT

Applicant Novabone Products, LLC

K number K080009

View details →

MQV 2008-05-02

OSFERION

Applicant Olympus Terumo Biomaterials Corporation

K number K080065

View details →

MQV 2008-04-21

PLEXUR-P

Applicant Osteotech, Inc.

K number K080511

View details →

MQV 2008-04-16

ACTIFUSE SHAPE BONE GRAFT SUBSTITUTE

Applicant Apatech , Ltd.

K number K080736

View details →

MQV 2008-04-15

COMPORUS

Applicant Takiron Co., Ltd.

K number K062691

View details →

MQV 2008-04-04

WELLGRAFT PE I

Applicant Gwowei Technology Co., Ltd.

K number K072444

View details →

MQV 2008-04-04

WELLGRAFT PE II

Applicant Gwowei Technology Co., Ltd.

K number K072170

View details →

MQV 2008-03-11

GRAFTYS BCP

Applicant Graftys

K number K073064

View details →

MQV 2008-03-10

MERRIES K-PHATE BONE GRAFT SUBSTITUTE

Applicant Merries International, Inc.

K number K063157

View details →

MQV 2008-03-03

PLEXUR M

Applicant Osteotech, Inc.

K number K073405

View details →

MQV 2008-02-01

BONALIVE GRANULES

Applicant Vivoxid , Ltd.

K number K071199

View details →

MQV 2008-01-25

BIOSET XCH

Applicant Regeneration Technologies, Inc.

K number K072238

View details →

MQV 2008-01-09

PROGENIX DMB PUTTY

Applicant Medtronic Sofamor Danek

K number K072265

View details →

MQV 2007-12-20

MICROFUSE BONE VOID FILLER

Applicant Globus Medical, Inc.

K number K071187

View details →

MQV 2007-12-17

CROSS.BONE

Applicant TriMed, Inc.

K number K071876

View details →

MQV 2007-11-19

CAP PLUS

Applicant Etex Corp.

K number K063050

View details →

MQV 2007-11-09

MASTERGRAFT PUTTY

Applicant Medtronic Sofamor Danek

K number K071813

View details →

MQV 2007-11-09

POLYGRAFT BGS

Applicant Smith & Nephew, Inc.

K number K062607

View details →

MQV 2007-10-29

APACERAM BONE GRAFT SUBSTITUTE

Applicant Pentax Corp.

K number K071912

View details →

MQV 2007-10-24

CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON

Applicant Regeneration Technologies, Inc.

K number K072327

View details →

MQV 2007-10-23

A-BSM BONE SUBSTITUTE MATERIAL

Applicant Etex Corp.

K number K072636

View details →

MQV 2007-10-23

SYNTHES CHRONOS COMPOSITE

Applicant Synthes (Usa)

K number K071046

View details →

MQV 2007-10-15

PRO-DENSE CORE DECOMPRESSION PROCEDURE KIT

Applicant Wrightmedicaltechnologyinc

K number K072597

View details →

MQV 2007-10-15

ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY

Applicant Isotis Orthobiologics, Inc.

K number K070751

View details →

MQV 2007-10-11

INION BIORESTORE

Applicant Inion OY

K number K070998

View details →

MQV 2007-09-26

OSSIFUSE BONE SUBSTITUTE MATERIAL

Applicant Etex Corp.

K number K072355

View details →

MQV 2007-09-21

MODIFICATION TO COPIOS BONE VOID FILLER SPONGE & PASTE

Applicant Kensey Nash Corp.

K number K072384

View details →

MQV 2007-09-18

VITOSS BIOACTIVE FOAM BONE GRAFT SUBSTITUTE

Applicant Orthovita, Inc.

K number K072184

View details →

MQV 2007-09-17

INQU

Applicant Isto Technologies, Inc.

K number K071428

View details →

MQV 2007-09-17

BONEMEDIK, AND BONEMEDIK-S

Applicant Meta Biomed Co., Ltd.

K number K070897

View details →

MQV 2007-09-11

TRIBONE 80

Applicant Biomatlante

K number K071121

View details →

MQV 2007-08-15

ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC

Applicant Isotis NV

K number K061880

View details →

MQV 2007-07-30

MBCP+

Applicant Biomatlante

K number K063527

View details →

MQV 2007-07-13

TRIPORE, MODELS HA, BP90, BP15

Applicant Orthogem Limited

K number K070132

View details →

MQV 2007-07-10

ATLANTIK

Applicant Medical Biomat

K number K070794

View details →

MQV 2007-07-03

MODIFICATION TO: BIOSORB RESORBABLE VOID FILLER

Applicant Science For Biomaterials

K number K071155

View details →

MQV 2007-06-28

OSSIPRO BONE SUBSTITUTE MATERIAL

Applicant Etex Corp.

K number K062630

View details →

MQV 2007-06-01

COPIOS BONE VOID FILLER SPONGE AND PASTE

Applicant Kensey Nash Corp.

K number K071237

View details →

MQV 2007-06-01

BONEPLAST QS CALCIUM SULFATE BONE VOID FILLER

Applicant Biomet Osteobiologics

K number K070864

View details →

MQV 2007-05-31

ACTIFUSE ABX E-Z-FIL PUTTY BONE GRAFT SUBSTITUTE

Applicant Apatech , Ltd.

K number K071206

View details →

MQV 2007-05-09

PRO-DENSE BONE VOID FILLER

Applicant Wrightmedicaltechnologyinc

K number K070437

View details →

MQV 2007-04-18

PRO OSTEON 500R

Applicant Ebi, L.P.

K number K063346

View details →

MQV 2007-04-16

INQU

Applicant Isto Technologies, Inc.

K number K063359

View details →