FDA.reportPublic FDA data

MectaBlast Granules

Primary DI
03760191134942
Brand
MectaBlast Granules
Company
NORAKER
Model
1-3 mm; 16cc
Catalog number
XMB-GL16
Device description
Bioactive Bone Substitute - Granule size 1-3 mm; 16cc
Published
2026-05-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
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
K242782000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242782000GlassBone GranulesNoraker2024-12-23MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760191134942PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760191134942037601911349423760191134942

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Total Volume0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
279959048
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760191133723GlassBone Granules1-3 mm; 5ccGB1.3/52026-05-27
03760191133730GlassBone Granules1-3 mm; 10ccGB1.3/102026-05-27
03760191133747GlassBone Granules1-3 mm; 16ccGB1.3/162026-05-27
03760191133754GlassBone Granules0.5-1mm; 5ccGB05.1/52026-05-27
03760191133761GlassBone Granules1-3 mm; 1ccGB1.3/1-U2026-05-27
03760191133778GlassBone Granules0.5-1mm; 1ccGB05.1/1-U2026-05-27
03760191133785GlassBone Granules0.5-1mm; 0.5ccGB05.1/05-U2026-05-27
03760191134812AktiBone Granules0.5-1mm; 0.5ccXAK-GM0.52026-05-27
03760191134829AktiBone Granules0.5-1mm; 1ccXAK-GM1.02026-05-27
03760191134836AktiBone Granules0.5-1mm; 5ccXAK-GM52026-05-27
03760191134843AktiBone Granules1-3 mm; 1ccXAK-GL1.02026-05-27
03760191134850AktiBone Granules1-3 mm; 5ccXAK-GL52026-05-27
03760191134867AktiBone Granules1-3 mm; 10ccXAK-GL102026-05-27
03760191134874AktiBone Granules1-3 mm; 16ccXAK-GL162026-05-27
03760191134881MectaBlast Granules0.5-1mm; 0.5ccXMB-GM0.52026-05-27
03760191134898MectaBlast Granules0.5-1mm; 1ccXMB-GM1.02026-05-27
03760191134904MectaBlast Granules0.5-1mm; 5ccXMB-GM52026-05-27
03760191134911MectaBlast Granules1-3 mm; 1ccXMB-GL1.02026-05-27
03760191134928MectaBlast Granules1-3 mm; 5ccXMB-GL52026-05-27
03760191134935MectaBlast Granules1-3 mm; 10ccXMB-GL102026-05-27

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Primary DI, Brand, Company table
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