FDA.reportPublic FDA data

Trigen

Primary DI
00885556816059
Brand
Trigen
Company
Smith & Nephew, Inc.
Model
XT001164-2
Catalog number
XT001164-2
Device description
FEMORAL ANTEGRADE KFN 10MM X 70CM LEFT
Published
2021-08-27
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
K061783000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061783000KNEE FUSION NAILSmith & Nephew, Inc.2006-08-10JDS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556816059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556816059008855568160598855568160590885556816059

GMDN Terms#

Term, Definition table
TermDefinition
Arthrodesis nail, sterileA sterile rod made of metal or other material (e.g., carbon fibre) designed to be inserted into the intramedullary canal of any long bone [e.g., femur, tibia, humerus (including fixation of the glenoid), talus, fibula, radius, ulna] to immobilize by holding the ends of a fractured or diseased bone together (i.e., in position) for the purpose of joint fusion or arthrodesis (an operation to permanently fix a joint in position). The device is used for traumatic repair or reconstructive procedures; it may include screws if locked into place. 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
00885554009101NA720770572077052015-08-30
00885556925690NAROB30080ROB300802026-06-04
03596010589101JOURNEY71422274714222742015-08-30
03596010589132JOURNEY71422277714222772015-08-30
03596010000675OXINIUM71343603713436032015-08-30
03596010474148OXINIUM71342800713428002015-08-30
03596010474162OXINIUM71342804713428042015-08-30
03596010474179OXINIUM71342808713428082015-08-30
03596010474209OXINIUM71343200713432002015-08-30
03596010474216OXINIUM71343203713432032015-08-30
03596010474223OXINIUM71343204713432042015-08-30
03596010474230OXINIUM71343208713432082015-08-30
03596010477279OXINIUM71343600713436002015-08-30
03596010477286OXINIUM71343604713436042015-08-30
03596010477293OXINIUM71343608713436082015-08-30
03596010488862OXINIUM71342200713422002015-08-30
03596010544193JOURNEY71461012714610122015-08-30
03596010544209JOURNEY71461013714610132015-08-30
03596010544216JOURNEY71461014714610142015-08-30
03596010544223JOURNEY71461015714610152015-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08905892004599GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004605GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004612GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004629GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004636GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004643GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004650GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004667GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004674GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004681GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004698GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004704GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004711GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004728GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004735GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004742GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004759GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004766GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004773GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004780GPCGPC MEDICAL LIMITEDJDS2024-01-31
08905892004568GPCGPC MEDICAL LIMITEDJDS2023-12-30
08905892004575GPCGPC MEDICAL LIMITEDJDS2023-12-30
08905892006968GPCGPC MEDICAL LIMITEDJDS2023-11-30
08905892006975GPCGPC MEDICAL LIMITEDJDS2023-11-30
08905892006982GPCGPC MEDICAL LIMITEDJDS2023-11-30
08905892006999GPCGPC MEDICAL LIMITEDJDS2023-11-30
08905892007002GPCGPC MEDICAL LIMITEDJDS2023-11-30
08905892007019GPCGPC MEDICAL LIMITEDJDS2023-11-30
08905892007026GPCGPC MEDICAL LIMITEDJDS2023-11-30
08905892007033GPCGPC MEDICAL LIMITEDJDS2023-11-30