FDA.reportPublic FDA data

TRIGEN

Primary DI
03596010560872
Brand
TRIGEN
Company
Smith & Nephew, Inc.
Model
71675208
Catalog number
71675208
Device description
TRIGEN INTERTAN 11.5MM X 18CM 130DEGREE
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
K210980000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040212000TRIGEN INTERTANSmith & Nephew, Inc.2004-02-20JDS
K210980000Smith & Nephew Intramedullary Nail SystemsSmith & Nephew, Inc.2022-11-14HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010560872PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010560872035960105608723596010560872

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
00885556918937NA72205810722058102026-08-19
00885556918968NA72205911722059112026-08-19
00885556919897NA72205802722058022026-08-19
00885556919965NA72205777722057772026-08-19
00885556919972NA72205778722057782026-08-19
00885556919989NA72205790722057902026-08-19
00885556919996NA72205791722057912026-08-19
00885556920008NA72205792722057922026-08-19
00885556920015NA72205793722057932026-08-19
00885556920022NA72205800722058002026-08-19
00885556920039NA72205801722058012026-08-19
00885556920046NA72205782722057822026-08-19
00885556920053NA72205803722058032026-08-19
00885556924433TESSA ACL FEM LIC NO CLOUD72205781722057812026-08-14
00885556924440TESSA72205783722057832026-08-14
00885556924457TESSA72205784722057842026-08-14
00885556924464NA72205785722057852026-08-14
00885556926680TESSA72205786722057862026-08-14
00885556926703TESSA72205787722057872026-08-14
00885556922170NA74034437740344372026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00193982471477AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982471491AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982471514AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
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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
00193982473921AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982473945AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982474171AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982474195AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14