FDA.reportPublic FDA data

TRIGEN TAN

Primary DI
03596010496799
Brand
TRIGEN TAN
Company
Smith & Nephew, Inc.
Model
71637136
Catalog number
71637136
Device description
TROCHANTERIC ANTEGRADE NAIL LIME 8.5MM X 36CM LT
Published
2015-11-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K981529000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K981529000TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREWSmith & Nephew, Inc.1998-07-09JDS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010496799PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010496799035960104967993596010496799

GMDN Terms#

Term, Definition table
TermDefinition
Femur nailA rod made of metal or other material intended to be implanted into the intramedullary canal of the femur to immobilize the ends of a fractured bone in position to promote healing; it also be used to support the bone in the presence of a pathological condition, or for knee arthrodesis. It may be a locked or unlocked model and may include 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
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
00193982473921AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982473945AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982474171AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14
00193982474195AUTOBAHNGLOBUS MEDICAL, INC.JDS2026-08-14