FDA.reportPublic FDA data

TALON

Primary DI
00840916134037
Brand
TALON
Company
SPINAL ELEMENTS
Model
TSP0010
Device description
10mm Talon Spacer
Published
2019-03-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
MNIOrthosis, Spinal Pedicle Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840916134037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840916134037008409161340378409161340370840916134037

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system rodAn implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
004022104
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840916156176TALONTL22342020-05-05
00840916156183TALONTL22352020-05-05
00840916156190TALONTL22362020-05-05
00840916156206TALONTL22372020-05-05
00840916156213TALONTL22382020-05-05
00840916107208OMNICT050502017-06-19
00840916107215OMNICT050552017-06-19
00840916107253OMNICT060502017-06-19
00840916107291OMNICT070452017-06-19
00840916107307OMNICT070502017-06-19
00840916107987OMNILCPT 100-K2017-06-27
00840916108007OMNILCPT 120-K2017-06-27
00840916108014OMNILCPT 130-K2017-06-27
00840916108021OMNILCPT 140-K2017-06-27
00840916108038OMNILCPT 150-K2017-06-27
00840916108045OMNILCPT 35-K2017-06-28
00840916108052OMNILCPT 40-K2017-06-28
00840916108069OMNILCPT 45-K2017-06-28
00840916108076OMNILCPT 50-K2017-06-28
00840916108083OMNILCPT 55-K2017-06-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806364689439Kora Spinal SystemMedyssey Co., Ltd.MNI2026-10-01
08806364690077Kora Spinal SystemMedyssey Co., Ltd.MNI2026-10-01
00840916134013TALONSPINAL ELEMENTSMNI2019-03-26
00840916134020TALONSPINAL ELEMENTSMNI2019-03-26
10888857001428DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001435DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001459DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001657DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001688DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001695DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001701DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001718DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
00840916111533TALONSPINAL ELEMENTSMNI2017-07-10
00840916111601TALONSPINAL ELEMENTSMNI2017-07-10
00840916111618TALONSPINAL ELEMENTSMNI2017-07-10
00840916111625TALONSPINAL ELEMENTSMNI2017-07-10
00840916111632TALONSPINAL ELEMENTSMNI2017-07-10
00840916111465TALONSPINAL ELEMENTSMNI2017-07-10
00840916111472TALONSPINAL ELEMENTSMNI2017-07-10
00840916111489TALONSPINAL ELEMENTSMNI2017-07-10
00840916111496TALONSPINAL ELEMENTSMNI2017-07-10
00840916111502TALONSPINAL ELEMENTSMNI2017-07-10
00840916111526TALONSPINAL ELEMENTSMNI2017-07-10
00840916111540TALONSPINAL ELEMENTSMNI2017-07-10
00840916111557TALONSPINAL ELEMENTSMNI2017-07-10
00840916111564TALONSPINAL ELEMENTSMNI2017-07-10
00840916111571TALONSPINAL ELEMENTSMNI2017-07-10
00840916111588TALONSPINAL ELEMENTSMNI2017-07-10
00840916111595TALONSPINAL ELEMENTSMNI2017-07-10
07613327170559VertaPlex HVSTRYKER CORPORATIONMNI2016-09-23