FDA.reportPublic FDA data

Synthacer

Primary DI
04250971400194
Brand
Synthacer
Company
medArtis Medizinprodukte und Forschung Aktiengesellschaft
Model
T6210TMO-1
Catalog number
6.210TMO
Device description
Synthacer® 600 cylinder, HA, size 10, diameter 12.75 mm, length 25 mm, without lid
Published
2015-10-24
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
K041177000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041177000SYNTHACER; SYNTRICERMedartis Medizinprodukte Und Forschung AG2005-06-23MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250971400194PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250971400194042509714001944250971400194

GMDN Terms#

Term, Definition table
TermDefinition
Bone matrix implant, syntheticA sterile 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 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
Length25Millimeter
Outer Diameter12.75Millimeter
Pore Size600Micrometer

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
313163545
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250971400002SynthacerT6201TMC-16.201TMC2017-10-24
04250971400019SynthacerT6201TMO-16.201TMO2017-10-24
04250971400026SynthacerT6202TMC-16.202TMC2017-10-24
04250971400033SynthacerT6202TMO-16.202TMO2017-10-24
04250971400040SynthacerT6203TMC-16.203TMC2017-10-24
04250971400057SynthacerT6203TMO-16.203TMO2017-10-24
04250971400064SynthacerT6204TMC-16.204TMC2015-10-24
04250971400071SynthacerT6204TMO-16.204TMO2015-10-24
04250971400088SynthacerT6205TMC-16.205TMC2015-10-24
04250971400095SynthacerT6205TMO-16.205TMO2015-10-24
04250971400101SynthacerT6206TMC-16.206TMC2015-10-24
04250971400118SynthacerT6206TMO-16.206TMO2015-10-24
04250971400125SynthacerT6207TMC-16.207TMC2015-10-24
04250971400132SynthacerT6207TMO-16.207TMO2015-10-24
04250971400149SynthacerT6208TMC-16.208TMC2015-10-24
04250971400156SynthacerT6208TMO-16.208TMO2015-10-24
04250971400163SynthacerT6209TMC-16.209TMC2015-10-24
04250971400170SynthacerT6209TMO-16.209TMO2015-10-24
04250971400187SynthacerT6210TMC-16.210TMC2015-10-24
04250971400200SynthacerT6211TMC-16.211TMC2015-10-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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ECURCCLF25100CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLF25250CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLF2550CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM25100CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM2512CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM2525CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM2550CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURTFF1050TriForm Flexible Foam Stripcurasan AGMQV2026-06-25
ECURTFF1100TriForm Flexible Foam Stripcurasan AGMQV2026-06-25
ECURTFM1050TriForm Moldable Foamcurasan AGMQV2026-06-25
ECURTFM1100TriForm Moldable Foamcurasan AGMQV2026-06-25
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06429810349316Adaptos®FuseBiomendex OyMQV2026-06-24
06429810349330Adaptos®FuseBiomendex OyMQV2026-06-24
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W4184058150T0474DBX®Musculoskeletal Transplant Foundation, Inc.MQV2026-06-05
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