FDA.reportPublic FDA data

SynMesh

Primary DI
10705034817910
Brand
SynMesh
Company
Synthes GmbH
Model
04.817.448
Catalog number
04817448
Device description
SYNMESH® 10MM DIA 88MM HEIGHT (TI)
Published
2019-12-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQPSpinal vertebral body replacement device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQPSpinal Vertebral Body Replacement DeviceOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183054000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183054000SYNMESH SystemDepuy Synthes Spine2019-05-23MQP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034817910PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503481791010705034817910

GMDN Terms#

Term, Definition table
TermDefinition
Vertebral body prosthesis, non-sterileA non-sterile implantable device designed to replace or repair (fuse) the spinal bony segments, or vertebrae, lost or injured as a consequence of, e.g., trauma, deformity, tumour, or degenerative disease. It is typically intended to be used with supplemental spinal fixation and may be used with a bone graft. It is usually made of metal, polymer, or a combination of these materials. This device must be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982342508VOLT02.535.724025357242026-09-25
10886982342515VOLT02.535.726025357262026-09-25
10886982342522VOLT02.535.728025357282026-09-25
10886982342539VOLT02.535.730025357302026-09-25
10886982342546VOLT02.535.732025357322026-09-25
10886982342553VOLT02.535.734025357342026-09-25
10886982342560VOLT02.535.736025357362026-09-25
10886982342577VOLT02.535.738025357382026-09-25
10886982342584VOLT02.535.740025357402026-09-25
10886982342591VOLT02.535.742025357422026-09-25
10886982342607VOLT02.535.744025357442026-09-25
10886982342614VOLT02.535.746025357462026-09-25
10886982342621VOLT02.535.748025357482026-09-25
10886982342638VOLT02.535.750025357502026-09-25
10886982342645VOLT02.535.752025357522026-09-25
10886982342652VOLT02.535.754025357542026-09-25
10886982342669VOLT02.535.756025357562026-09-25
10886982342676VOLT02.535.758025357582026-09-25
10886982342683VOLT02.535.760025357602026-09-25
10886982344878VOLT02.535.765025357652026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888857461819CASCADIA™ Interbody SystemVB Spine LLCMQP2019-10-31
10888857461888CASCADIA™ Interbody SystemVB Spine LLCMQP2019-10-31
10888857218772CASCADIA™ Interbody SystemVB Spine LLCMQP2015-12-16
10888857218963CASCADIA™ Interbody SystemVB Spine LLCMQP2015-12-16
10888857219076CASCADIA™ Interbody SystemVB Spine LLCMQP2015-12-16
10888857219489CASCADIA™ Interbody SystemVB Spine LLCMQP2015-12-16
10888857219595CASCADIA™ Interbody SystemVB Spine LLCMQP2015-12-16
04546540389084VBOSSStryker CorporationMQP2015-09-14
04546540389091VBOSSStryker CorporationMQP2015-09-14
04546540389107VBOSSStryker CorporationMQP2015-09-14
04546540389114VBOSSStryker CorporationMQP2015-09-14
04546540389121VBOSSStryker CorporationMQP2015-09-14
04546540389138VBOSSStryker CorporationMQP2015-09-14
04546540389145VBOSSStryker CorporationMQP2015-09-14
04546540389152VBOSSStryker CorporationMQP2015-09-14
04546540389169VBOSSStryker CorporationMQP2015-09-14
04546540389176VBOSSStryker CorporationMQP2015-09-14
04546540389183VBOSSStryker CorporationMQP2015-09-14
04546540389190VBOSSStryker CorporationMQP2015-09-14
04546540389206VBOSSStryker CorporationMQP2015-09-14
04546540389213VBOSSStryker CorporationMQP2015-09-14
04546540389220VBOSSStryker CorporationMQP2015-09-14
04546540389237VBOSSStryker CorporationMQP2015-09-14
04546540389244VBOSSStryker CorporationMQP2015-09-14
04546540389251VBOSSStryker CorporationMQP2015-09-14
04546540389268VBOSSStryker CorporationMQP2015-09-14
04546540389275VBOSSStryker CorporationMQP2015-09-14
04546540389282VBOSSStryker CorporationMQP2015-09-14
04546540389299VBOSSStryker CorporationMQP2015-09-14
04546540389305VBOSSStryker CorporationMQP2015-09-14