FDA.reportPublic FDA data

TALON

Primary DI
00840916110864
Brand
TALON
Company
SPINAL ELEMENTS
Model
T80075-C
Device description
75mm Flex 5.5mm Pre-Bent Rod
Published
2017-07-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MNHOrthosis, Spondylolisthesis Spinal Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840916110864PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840916110864008409161108648409161108640840916110864

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
004022104
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840916123710ZEUS-T67-2811122017-08-01
00840916162115DIAMOND100402022-03-03
00840916162122DIAMOND100432022-03-03
00840916162139DIAMOND100472022-03-03
00840916142926ZEUS-O101122021-01-11
00840916143008ZEUS-O109972021-01-11
00840916160135SPARTAN103132020-12-07
00840916156947ZEUS-O105002020-05-11
00840916117603SLPSS82192017-08-10
00840916149840SAVANNAH91052020-04-16
00840916150143SAVANNAH82712020-04-16
00840916150150SAVANNAH90012020-04-16
00840916150167SAVANNAH90022020-04-16
00840916150174SAVANNAH90042020-04-16
00840916150211SAVANNAH90502020-04-16
00840916150228SAVANNAH90902020-04-16
00840916115555SAMSON135142017-08-01
00840916115562SAMSON135152017-08-01
00840916115579SAMSON135162017-08-01
00840916115586SAMSON135172017-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00613994887955TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2015-09-17
00885074494722TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2015-08-05
00613994568311TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2015-08-05
00613994568823TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2015-08-05
00613994888143TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2015-08-05
04546540147257XIA IIStryker CorporationMNH2014-12-08
04546540147769XIA IIStryker CorporationMNH2014-12-08
04546540147806XIA IIStryker CorporationMNH2014-12-08
04546540147905XIA IIStryker CorporationMNH2014-12-08
04546540147912XIA IStryker CorporationMNH2014-12-08
04546540147929XIA IStryker CorporationMNH2014-12-08
04546540147936XIA IStryker CorporationMNH2014-12-08
04546540147974XIA IStryker CorporationMNH2014-12-08
04546540147981XIA IStryker CorporationMNH2014-12-08
04546540147998XIA IStryker CorporationMNH2014-12-08
04546540148001XIA IIStryker CorporationMNH2014-12-08
04546540148018XIA IIStryker CorporationMNH2014-12-08
04546540148025XIA IIStryker CorporationMNH2014-12-08
04546540148735XIA IIStryker CorporationMNH2014-12-08
04546540148742XIA IIStryker CorporationMNH2014-12-08
04546540148759XIA IIStryker CorporationMNH2014-12-08
04546540148766XIA IIStryker CorporationMNH2014-12-08
04546540148773XIA IIStryker CorporationMNH2014-12-08
04546540148780XIA IIStryker CorporationMNH2014-12-08
04546540148797XIA IIStryker CorporationMNH2014-12-08
04546540148803XIA IIStryker CorporationMNH2014-12-08
04546540148810XIA IIStryker CorporationMNH2014-12-08
04546540148827XIA IIStryker CorporationMNH2014-12-08
04546540148834XIA IIStryker CorporationMNH2014-12-08
04546540148841XIA IIStryker CorporationMNH2014-12-08