FDA.reportPublic FDA data

Bonalive Orthopedics granules

Primary DI
06438132143403
Brand
Bonalive Orthopedics granules
Company
Bonalive Oy
Model
14340
Catalog number
14340
Device description
Synthetic bone substitute for regenerating bone
Published
2020-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K191274000
K231528000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191274000BonAlive GranulesBonalive Biomaterials, Ltd.2019-08-07MQV
K231528000Bonalive Orthopedics granulesBonalive Biomaterials, Ltd.2023-07-11MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06438132143403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438132143403064381321434036438132143403

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume10Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+358401774400contact@bonalive.com

Regulatory Flags#

DUNS number
367881400
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06438132141102Bonalive Orthopedics granules14110141102020-08-31
06438132141201Bonalive Orthopedics granules14120141202020-08-31
06438132141300Bonalive Orthopedics granules14130141302020-08-31
06438132141409Bonalive Orthopedics granules14140141402020-08-31
06438132143304Bonalive Orthopedics granules14330143302020-08-31

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Primary DI, Brand, Company table
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