FDA.reportPublic FDA data

OsteoXcell BA

Primary DI
05060548020231
Brand
OsteoXcell BA
Company
BIOSTONE CO. LIMITED
Model
OSBA-003
Catalog number
OSBA-003
Device description
Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 3 cc suspended in a biocompatible hydrogel solution packed in a 14ml open bore syringe. They are packed in a vacuum sealed foil inner pouch within a Tyvek outer pouch and packed in a carton box
Published
2024-07-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MQVFiller, Bone Void, Calcium Compound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202639000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202639000si-MochiBiostone, Ltd.2021-04-21MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060548020231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060548020231050605480202315060548020231

GMDN Terms#

Term, Definition table
TermDefinition
Bone matrix implant, synthetic, non-antimicrobialA bioabsorbable device made of synthetic material intended to be implanted into the body to provide osteoconductive bone-tissue scaffolds, and sometimes osteovascularization, to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis); it does not include an antimicrobial agent(s). It may be made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), bioactive glasses/minerals/metals (e.g., strontium), or bioabsorbable polymers. It is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts and is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable/fluid materials.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
222236587
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060548020620InteliGraft™IG-SBG01IG-SBG012025-12-10
05060548020637InteliGraft™IG-SBG02IG-SBG022025-12-10
05060548020644InteliGraft™IG-SBG03IG-SBG032025-12-10
05060548020651InteliGraft™IG-SBG05IG-SBG052025-12-10
05060548020668InteliGraft™IG-SBG10IG-SBG102025-12-10
05060548020675InteliGraft™IG-MIS-SBG05IG-MIS-SBG052025-12-10
05060548020682InteliGraft™IG-MIS-SBG10IG-MIS-SBG102025-12-10
05060548020354BioViveSBG1DE-OBS-011DE-OBS-012024-12-02
05060548020361BioViveSBG1DE-OBS-021DE-OBS-022024-12-02
05060548020378BioViveSBG1DE-OBS-031DE-OBS-032024-12-02
05060548020385BioViveSBG1DE-OBS-051DE-OBS-052024-12-02
05060548020392BioViveSBG1DE-OBS-101DE-OBS-102024-12-02
05060548020408BioViveSBG1DE-MIS-051DE-MIS-052024-12-02
05060548020415BioViveSBG1DE-MIS-101DE-MIS-102024-12-02
05060548020293SynthaGen HaTCPOBS-1202-FOOBS-1202-FO2024-08-19
05060548020330SynthaGen HaTCPMIS-1205-FOMIS-1205-FO2024-08-19
05060548020347SynthaGen HaTCPMIS-1210-FOMIS-1210-FO2024-08-19
05060548020217OsteoXcell BAOSBA-001OSBA-0012024-07-18
05060548020224OsteoXcell BAOSBA-002OSBA-0022024-07-18
05060548020248OsteoXcell BAOSBA-005OSBA-0052024-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760191133723GlassBone GranulesNORAKERMQV2026-05-27
03760191133730GlassBone GranulesNORAKERMQV2026-05-27
03760191133747GlassBone GranulesNORAKERMQV2026-05-27
03760191133754GlassBone GranulesNORAKERMQV2026-05-27
03760191133761GlassBone GranulesNORAKERMQV2026-05-27
03760191133778GlassBone GranulesNORAKERMQV2026-05-27
03760191133785GlassBone GranulesNORAKERMQV2026-05-27
03760191134812AktiBone GranulesNORAKERMQV2026-05-27
03760191134829AktiBone GranulesNORAKERMQV2026-05-27
03760191134836AktiBone GranulesNORAKERMQV2026-05-27
03760191134843AktiBone GranulesNORAKERMQV2026-05-27
03760191134850AktiBone GranulesNORAKERMQV2026-05-27
03760191134867AktiBone GranulesNORAKERMQV2026-05-27
03760191134874AktiBone GranulesNORAKERMQV2026-05-27
03760191134881MectaBlast GranulesNORAKERMQV2026-05-27
03760191134898MectaBlast GranulesNORAKERMQV2026-05-27
03760191134904MectaBlast GranulesNORAKERMQV2026-05-27
03760191134911MectaBlast GranulesNORAKERMQV2026-05-27
03760191134928MectaBlast GranulesNORAKERMQV2026-05-27
03760191134935MectaBlast GranulesNORAKERMQV2026-05-27
03760191134942MectaBlast GranulesNORAKERMQV2026-05-27
M263W21000WizardBio Resorbable Calcium Phosphate CementDSM BIOMEDICAL, INC.MQV2019-01-02
M263W23000WizardBio Resorbable Calcium Phosphate CementDSM BIOMEDICAL, INC.MQV2019-01-02
08719699710122MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710276MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710283MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710290MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710306MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710313MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710320MagnetOsKuros Biosciences B.V.MQV2018-01-08