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 2003-11-05

VITOSS-FILLED CARTRIDGE

Applicant Orthovita, Inc.

K number K032130

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MQV 2003-10-30

PROFUSION BONE VOID FILLER KIT

Applicant Biogeneration

K number K031838

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MQV 2003-08-29

VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER

Applicant Orthovita, Inc.

K number K032409

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MQV 2003-08-13

MODIFICATION TO CERASORB ORTHO

Applicant Curasan AG

K number K031651

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MQV 2003-08-04

BONESOURCE BVF

Applicant Howmedica Osteonics

K number K031435

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MQV 2003-07-24

THERIFIL BONE FILLER

Applicant Therics, Inc.

K number K031040

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MQV 2003-07-17

CELLPLEX TCP SYNTHETIC CANCELLOUS BONE

Applicant Wrightmedicaltechnologyinc

K number K031817

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MQV 2003-07-17

OSTEO-G BONE VOID FILLER SYSTEM

Applicant Aspine USA, Inc.

K number K031319

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MQV 2003-07-17

POLYGRAFT BONE GRAFT SUBSTITUTE

Applicant Osteobiologics, Inc.

K number K030288

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MQV 2003-05-20

CALLOS

Applicant Skeletal Kinetics, LLC

K number K030554

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MQV 2003-05-20

OSSATURA BCP BONE VOID FILLER

Applicant Isotis NV

K number K030131

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MQV 2003-04-22

MASTERGRAFT MATRIX

Applicant Medtronic Sofamor Danek, Inc.

K number K023553

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MQV 2003-03-04

MIIG II BONE GRAFT SUBSTITUTE

Applicant Wrightmedicaltechnologyinc

K number K024336

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MQV 2003-02-26

CALCIGEN PSI BONE GRAFT SUBSTITUTE

Applicant Biomet, Inc.

K number K030178

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MQV 2003-02-25

JAX

Applicant Smith & Nephew, Inc.

K number K010555

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MQV 2003-02-20

CEM-OSTETIC BONE; CEMO-10G, CEMO-20G, CEMO-30G, CEMO-40G, CEMO-60G, CEM0-XXGC; CEMO-XYZ202005P, CEMO-XYZ20210P, CEMO-XYZ

Applicant Berkeley Advanced Biomaterials, Inc.

K number K030266

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MQV 2003-01-30

BI-OSTETIC

Applicant Berkeley Advanced Biomaterials, Inc.

K number K023703

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MQV 2003-01-28

BIOSORB RESORBABLE VOID FILLER

Applicant Sciences ET Bio Materiaux (Sbm)

K number K021963

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MQV 2003-01-09

CEM-OSTETIC, MODELS CEMO-020O, CEMO-05P, CEMO-10P, CEMO-20P, AND CEMO-30P

Applicant Berkeley Advanced Biomaterials, Inc.

K number K022622

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MQV 2002-12-19

NORIAN XR CALCIUM PHOSPHATE BONE VOID FILLER

Applicant Synthes (Usa)

K number K023862

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MQV 2002-11-26

CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP)

Applicant Synthes

K number K013072

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MQV 2002-11-05

WMT-TCP BONE GRAFT SUBSTITUTE

Applicant Wrightmedicaltechnologyinc

K number K022629

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MQV 2002-11-01

STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT

Applicant Biocomposites, Ltd.

K number K021551

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MQV 2002-09-06

CALCIUM PHOSPHATE GRANULAR BONE VOID FILLER

Applicant Biomet, Inc.

K number K011531

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MQV 2002-07-25

NOVABONE-RESORBABLE BONE GRAFT SUBSTITUTE

Applicant Novabone Products, LLC

K number K021336

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MQV 2002-07-22

MASTERGRAFT RESORBABLE CERAMIC

Applicant Medtronic Sofamor Danek, Inc.

K number K020986

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MQV 2002-06-11

CALCIGEN-S BONE VOID FILER

Applicant Biomet Orthopedics, Inc.

K number K013790

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MQV 2002-05-23

APATIGHT HA-BONE GRAFT SUBSTITUTE

Applicant Cerabio, LLC

K number K013960

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MQV 2002-05-16

APATIGHT-TCP BONE GRAFT SUBSTITUTE

Applicant Cerabio, LLC

K number K013966

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MQV 2002-05-16

MILLENIUM'S SKELITE SYNTHETIC RESORBABLE BONE VOID FILLER

Applicant Millenium Biologix, Inc.

K number K011726

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MQV 2002-03-18

CERASORB ORTHO

Applicant Curasan AG

K number K014156

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MQV 2002-03-08

CONDUIT TCP GRANULES

Applicant Depuyacromed

K number K014053

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MQV 2002-03-07

MASTERGRAFT RESORBABLE CERAMIC GRANULES

Applicant Medtronic Sofamor Danek USA, Inc.

K number K012506

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MQV 2001-12-20

NORIAN SRS BONE VOID FILLER

Applicant Synthes (Usa)

K number K011897

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MQV 2001-11-14

HEALOS BONE GRAFT MATERIAL

Applicant Orquest, Inc.

K number K012751

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MQV 2001-11-13

BSM BONE SUBSTITUTE MATERIAL

Applicant DePuy Orthopaedics, Inc.

K number K011048

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MQV 2001-10-26

OSTEOSET BVF KIT

Applicant Wrightmedicaltechnologyinc

K number K010532

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MQV 2001-09-20

COLLAGRAFT STRIP BONE GRAFT MATRIX (FOR USE AS A BONE FILLER), MODEL 1X,3X,6X (1,3 OR 6 STRIPS PER BOX)

Applicant Neucoll, Inc.

K number K000122

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MQV 2001-08-03

EBI OSTEOSTIM GRANULES-RESORBABLE BONE GRAFT SUBSTITUTE

Applicant Ebi, L.P.

K number K011386

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MQV 2001-07-19

PRO OSTEON 200R WITH CALCIUM SULFATE, MODELS 2RCS038, 2RCS050, 2RCS075, 2RCS10, 2RCS15, 2RCS20, 2RCS225, 2RCS30

Applicant Interpore Cross Intl.

K number K004003

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MQV 2001-07-12

STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT

Applicant Biocomposites, Ltd.

K number K003954

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MQV 2001-05-25

JAX GRANULES BONE VOID FILLER

Applicant Smith & Nephew, Inc.

K number K010557

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MQV 2000-12-14

VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER

Applicant Orthovita Co.

K number K994337

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MQV 2000-11-01

SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS)

Applicant Synthes (Usa)

K number K002362

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MQV 2000-09-15

PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150,

Applicant Interpore Cross Intl.

K number K000515

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MQV 2000-08-04

STIMULAN -CALCIUM SULFATE BONE VOID FILTER

Applicant Biocomposites, Ltd.

K number K001724

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MQV 2000-06-20

CALCIUM SULFATE PELLETS

Applicant Howmedica Osteonics Corp.

K number K001559

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MQV 1999-08-26

OSTEOPLAST, MODEL POP200

Applicant Interpore Cross Intl.

K number K991854

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MQV 1999-03-02

PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE

Applicant Interpore Cross Intl.

K number K990131

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MQV 1999-02-26

STIMULAN- CALCIUM SULFATE BONE VOID FILLER

Applicant Encore Orthopedics, Inc.

K number K982663

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MQV 1998-09-25

PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE MODEL NUMBERS 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L

Applicant Interpore Intl.

K number K980817

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MQV 1998-04-03

PROFUSION BONE VOID FILLER

Applicant Biogeneration

K number K973704

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MQV 1997-05-07

WRIGHT PLASTER OF PARIS PELLETS

Applicant Wrightmedicaltechnologyinc

K number K963562

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MQV 1997-03-24

WRIGHT PLASTER OF PARIS BONE VOID FILLER KIT (SUBJECT TO REVISION)

Applicant Wrightmedicaltechnologyinc

K number K963587

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MQV 1996-06-21

WRIGHT PLASTER OF PARIS PELLETS (SUBJECT TO REVISION)

Applicant Wrightmedicaltechnologyinc

K number K960978

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