FDA.reportPublic FDA data

TRIGEN

Primary DI
00885556344897
Brand
TRIGEN
Company
Smith & Nephew, Inc.
Model
71675524
Catalog number
71675524
Device description
TRIGEN INTERTAN 10S 10MM X 26CM 130DEGREE RIGHT
Published
2017-11-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDSNAIL, FIXATION, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDSNail, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040212000
K241804000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040212000TRIGEN INTERTANSmith & Nephew, Inc.2004-02-20JDS
K241804000TRIGEN INTERTAN 10S Nail SystemSmith & Nephew, Inc.2024-08-22JDS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556344897PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556344897008855563448978855563448970885556344897

GMDN Terms#

Term, Definition table
TermDefinition
Femur nail, sterileA sterile rod made of metal or other material which, when inserted into the intramedullary canal of the femur, acts to immobilize by holding the ends of a fractured bone in position to promote healing. The device may also be used to support the bone in the presence of a pathological condition, or for knee arthrodesis. The device may be a locked or unlocked model, and possess components to assist fixation of more proximal or distal conditions. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03596010619952NA72201597722015972015-08-29
03596010619969NA72201598722015982015-08-29
00885556572351NA72201597S72201597S2017-06-15
00885556572368NA72201598S72201598S2017-06-15
00885556830543PyroCarbon Modular Radial HeadTRL-310-01TRL-310-012026-09-24
00885556830550PyroCarbon Modular Radial HeadTRL-310-02TRL-310-022026-09-24
00885556830567PyroCarbon Modular Radial HeadTRL-310-03TRL-310-032026-09-24
00885556830574PyroCarbon Modular Radial HeadTRL-310-04TRL-310-042026-09-24
00885556839690Total Foot System 2CSA-800-06CSA-800-062026-09-24
00885556839706Total Foot System 2CSA-800-07CSA-800-072026-09-24
00885556854778Cadence Total Ankle SystemCSA-1020-0014CSA-1020-00142026-09-24
00885556859636Titan Modular Shoulder SystemCSA092009CSA0920092026-09-24
00885556859643Titan Modular Shoulder SystemCSA092010CSA0920102026-09-24
00885556859650Titan Modular Shoulder SystemCSA092011CSA0920112026-09-24
00885556859698Titan Modular Shoulder SystemCSA-0920-15CSA-0920-152026-09-24
00885556859704Titan Modular Shoulder SystemCSA-0920-16CSA-0920-162026-09-24
00885556859711Titan Modular Shoulder SystemCSA-0920-17CSA-0920-172026-09-24
00885556859728Titan Modular Shoulder SystemCSA-0920-18CSA-0920-182026-09-24
00885556859735Titan Modular Shoulder SystemCSA-0920-19CSA-0920-192026-09-24
00885556859742Titan Modular Shoulder SystemCSA-0920-20CSA-0920-202026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840124526044FibFixFUSION ORTHOPEDICS, LLCJDS2026-09-25
00840124526051FibFixFUSION ORTHOPEDICS, LLCJDS2026-09-25
00840124526068FibFixFUSION ORTHOPEDICS, LLCJDS2026-09-25
00840124526075FibFixFUSION ORTHOPEDICS, LLCJDS2026-09-25
00193982471415AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982471439AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982471453AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982471477AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982471491AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982471514AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982471538AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982471767AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982471781AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982471804AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982471828AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982471842AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982471866AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982471880AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982472115AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982472139AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982472153AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982472177AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982472191AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982472214AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982472238AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982473822AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982473846AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982473860AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982473884AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982473907AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14