FDA.reportPublic FDA data

Syntricer

Primary DI
04250971406264
Brand
Syntricer
Company
medArtis Medizinprodukte und Forschung Aktiengesellschaft
Model
T7N203TMO-1
Catalog number
7.N203TMO
Device description
"Syntricer® 600 cylinder, ""negative"", TCP, size 3, diameter 5.45 mm, length 15 mm, without lid"
Published
2017-10-24
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
04250971406264PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250971406264042509714062644250971406264

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
Length15Millimeter
Outer Diameter5.45Millimeter
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
04250971400194SynthacerT6210TMO-16.210TMO2015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
W4184058150T0474DBX®Musculoskeletal Transplant Foundation, Inc.MQV2026-06-05
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