FDA.reportPublic FDA data

GRAFTYS® QUICKSET

Primary DI
03760177571624
Brand
GRAFTYS® QUICKSET
Company
GRAFTYS
Model
16cc
Catalog number
GYQSMUSV1Q16
Device description
Injectable Macroporous Calcium Phosphate
Published
2024-03-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K093343000
K231714000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093343000GRAFTY QUICKSETGraftys2010-04-22MQV
K231714000Graftys QuicksetGraftys2023-07-12MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760177571624PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760177571624037601775716243760177571624

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 Volume16Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+33442603000CONTACT@GRAFTYS.COM

Regulatory Flags#

DUNS number
280930053
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760177571396GRAFTYS® QUICKSET KIT5ccQSMKITUSV1Q52024-03-20
03760177571402GRAFTYS® QUICKSET KIT8ccQSMKITUSV1Q82024-03-20
03760177571419GRAFTYS® QUICKSET KIT16ccQSMKITUSV1Q162024-03-20
03760177571600GRAFTYS® QUICKSET5ccGYQSMUSV1Q52024-03-20
03760177571617GRAFTYS® QUICKSET8ccGYQSMUSV1Q82024-03-20
03760177571655GRAFTYS® DELIVERING GUNGYINJECTSGYINJECTS2024-03-20

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Primary DI, Brand, Company table
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ECURTFM1100TriForm Moldable Foamcurasan AGMQV2026-06-25
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W4184058150T0474DBX®Musculoskeletal Transplant Foundation, Inc.MQV2026-06-05
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