FDA.reportPublic FDA data

Trigen

Primary DI
00885556871102
Brand
Trigen
Company
Smith & Nephew, Inc.
Model
XT001168-1
Catalog number
XT001168-1
Device description
META RETROGRADE FEMORAL NAIL 11.5MM X 40CM 125DEG RIGHT
Published
2022-02-06
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
K051557000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051557000TRIGEN RETROGRADE FEMORAL, SUPRACONDYLAR AND TIBIAL NAILSSmith & Nephew, Inc.2005-06-30JDS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556871102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556871102008855568711028855568711020885556871102

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
00885556917435Real IntelligenceROB20040ROB200402024-04-10
00885556780886REAL INTELLIGENCEROB10013SROB10013S2022-01-13
00885556757321REAL INTELLIGENCEROB10013ROB100132020-07-02
03596010411020VERSABOND71271140712711402015-08-29
03596010494726VERSABOND71271340712713402015-08-29
03596010507372VERSABOND71271440712714402015-09-28
03596010033246NA1100281100282015-08-25
03596010038852NA1114301114302015-08-25
03596010038890NA1114341114342015-08-25
03596010041968BUCK1124281124282015-08-25
03596010384591MIXOR71270041712700412015-08-29
03596010384607MIXOR71270042712700422015-08-29
03596010384638MIXOR71270051712700512015-08-29
03596010384645MIXOR71270052712700522015-08-29
03596010437617RENOVATION71369045713690452015-08-30
03596010472175MIXOR71270060712700602015-08-29
03596010515018VORTEX71272001712720012015-08-29
03596010040077NA1118021118022015-08-25
00885556582213RALLY71271560712715602015-10-08
00885556582220RALLY71271570712715702015-10-08

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