FDA.reportPublic FDA data

TALON

Primary DI
00840916110925
Brand
TALON
Company
SPINAL ELEMENTS
Model
T80090-C
Device description
90mm 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
00840916110925PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840916110925008409161109258409161109250840916110925

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
Manufacturing date on label
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
10888857037953EVEREST® Spinal SystemVB Spine LLCMNH2026-06-11
10888857037977EVEREST® Spinal SystemVB Spine LLCMNH2026-06-11
10888857001428DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001435DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001459DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001657DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001688DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001695DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001701DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001718DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857046733MESA® Small Stature Spinal SystemVB Spine LLCMNH2016-09-02
10888857008724EVEREST® Spinal SystemVB Spine LLCMNH2016-03-10
10888857001497DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001527DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001589DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001619DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001640DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001725DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001763DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001787DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001824DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001848DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001923DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001947DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001978DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001992DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857002036DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857002050DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857002074DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857002098DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24