FDA.reportPublic FDA data

NA

Primary DI
10705034739359
Brand
NA
Company
Synthes GmbH
Model
04.614.521
Catalog number
04614521
Device description
TI TRANSCONNECTOR LOCKING NUT 7.5MM
Published
2015-09-14
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
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
MNHOrthosis, spondylolisthesis spinal fixation
MNIORTHOSIS, SPINAL PEDICLE FIXATION
NKGOrthosis, cervical pedicle screw spinal fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKGPosterior Cervical Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034739359PrimaryGS10
H981046145210SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503473935910705034739359

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone set screwA small, implantable, non-bioabsorbable disc, threaded on its outside surface, intended to be threaded into the internal proximal end of a spinal bone screw head/rod adaptor, anchor, connector and/or hook (none included) to secure/stabilize a rod and/or tether as part of an internal spinal fixation procedure or a treatment for idiopathic scoliosis. It is made of metal (e.g., surgical steel, titanium alloy).

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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982312327NA68.134.011681340112026-10-16
10886982346704VOLT68.134.111681341112026-10-16
10886982346735VOLT68.134.200681342002026-10-16
10886982363282NA68.045.017680450172026-10-16
10886982363299NA68.045.018680450182026-10-16
10886982363305NA68.045.019680450192026-10-16
10886982363312NA68.045.020680450202026-10-16
10705034753690ChronOS07.801.100.99S0780110099S2015-09-14
10705034753706ChronOS07.801.101.99S0780110199S2015-09-14
10705034753713ChronOS07.801.110.99S0780111099S2015-09-14
10705034753720ChronOS07.801.111.99S0780111199S2015-09-14
10705034753737ChronOS07.801.200.99S0780120099S2015-09-14
10705034799933ChronOS710.002.99S71000299S2015-09-14
10705034799940ChronOS710.014.99S71001499S2015-09-14
10705034799957ChronOS710.019.99S71001999S2015-09-14
10705034799964ChronOS710.021.99S71002199S2015-09-14
10705034799971ChronOS710.025.99S71002599S2015-09-14
10705034799988ChronOS710.026.99S71002699S2015-09-14
10705034799995ChronOS710.027.99S71002799S2015-09-14
10705034800004ChronOS710.038.99S71003899S2015-09-14

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