FDA.reportPublic FDA data

si_Mochi

Primary DI
05060548020033
Brand
si_Mochi
Company
BIOSTONE CO. LIMITED
Model
MIS1210
Device description
Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 10cc suspended in a biocompatible hydrogel solution packed in two long cartridges ( 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 are sealed in an outer Tyvek pouch and 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
05060548020033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060548020033050605480200335060548020033

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
W4184058150T0474DBX®Musculoskeletal Transplant Foundation, Inc.MQV2026-06-05
07610221017829Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017836Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017843Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017850Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017867Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017874Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017881Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017898Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017904Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017911Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017928Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
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