FDA.reportPublic FDA data

si_Mochi

Primary DI
05060548020026
Brand
si_Mochi
Company
BIOSTONE CO. LIMITED
Model
MIS1205
Device description
Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 5cc suspended in a biocompatible hydrogel solution packed in one long cartridge ( 185 mm in length, inner diameter 6 mm, outer diameter 8 mm)sealed in a vacuum foil pouch. 185 mm long plunger & 100 mm short plunger sealed in a Tyvek pouch. Both foiled pouch & Tyvek pouch sealed in an outer Tyvek pouch. Then packed in a carton box.
Published
2022-07-25
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
05060548020026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060548020026050605480200265060548020026

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic bone graftAn artificial bone substitute used for structural bone replacement typically when bone is lost due to disease (e.g., osteoporosis) or injury. It consists mainly of porous and mesh ceramic materials that provide a framework for bone growth, or harvested sea coral that serves as an additive, extender, or provides a framework for bone growth. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
222236587
Device count
1
Lot or batch
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
05060548020231OsteoXcell BA OSBA-003OSBA-0032024-07-18

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00816125027132VitaFuse™ Bioactive Glass GraftBERKELEY ADVANCED BIOMATERIALS, LLCMQV2026-07-06
00816125027149VitaFuse™ Bioactive Glass GraftBERKELEY ADVANCED BIOMATERIALS, LLCMQV2026-07-06
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ECUR9920310VerteFramecurasan AGMQV2026-06-25
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ECURCCLF25250CERACELL Ortho Foamcurasan AGMQV2026-06-25
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ECURCCLM25100CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM2512CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM2525CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM2550CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURTFF1050TriForm Flexible Foam Stripcurasan AGMQV2026-06-25
ECURTFF1100TriForm Flexible Foam Stripcurasan AGMQV2026-06-25
ECURTFM1050TriForm Moldable Foamcurasan AGMQV2026-06-25
ECURTFM1100TriForm Moldable Foamcurasan AGMQV2026-06-25
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00849777014069Union DBM, 2.5ccXtant Medical Holdings, Inc.MQV2026-06-24
00849777014076Union DBM, 5ccXtant Medical Holdings, Inc.MQV2026-06-24
00849777014083Union DBM, 10ccXtant Medical Holdings, Inc.MQV2026-06-24
06429810349293Adaptos®FuseBiomendex OyMQV2026-06-24
06429810349316Adaptos®FuseBiomendex OyMQV2026-06-24
06429810349330Adaptos®FuseBiomendex OyMQV2026-06-24
06429810349354Adaptos®FuseBiomendex OyMQV2026-06-24
W4184058150T0474DBX®Musculoskeletal Transplant Foundation, Inc.MQV2026-06-05
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