FDA.reportPublic FDA data

GRAFTYS® QUICKSET KIT

Primary DI
03760177571419
Brand
GRAFTYS® QUICKSET KIT
Company
GRAFTYS
Model
16cc
Catalog number
QSMKITUSV1Q16
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
03760177571419PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760177571419037601775714193760177571419

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
Kit
true
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
03760177571600GRAFTYS® QUICKSET5ccGYQSMUSV1Q52024-03-20
03760177571617GRAFTYS® QUICKSET8ccGYQSMUSV1Q82024-03-20
03760177571624GRAFTYS® QUICKSET16ccGYQSMUSV1Q162024-03-20
03760177571655GRAFTYS® DELIVERING GUNGYINJECTSGYINJECTS2024-03-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
03760191134928MectaBlast GranulesNORAKERMQV2026-05-27