FDA.reportPublic FDA data

Jet-X

Primary DI
00885556056660
Brand
Jet-X
Company
Smith & Nephew, Inc.
Model
71931745
Catalog number
71931745
Device description
5MM X 70MM X 250MM X 1.6MM CANNULATED HALF PIN
Published
2015-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal CompositeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K953397000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K953397000HEX-FIX FIELD FIXATORSmith & Nephew Richards, Inc.1995-10-31LXT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556056660PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556056660008855560566608855560566600885556056660

GMDN Terms#

Term, Definition table
TermDefinition
External orthopaedic fixation system, single-use, sterileAn assembly of sterile devices designed to stabilize fractured bones of the lower limbs to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur and tibia, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Sterilization required before use
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
08800089416585INLET System Bone ScrewJeil Medical CorporationLXT2021-11-18
08800089416592INLET System Bone ScrewJeil Medical CorporationLXT2021-11-18
08800089416608INLET System Bone ScrewJeil Medical CorporationLXT2021-11-18
08800089416615INLET System Bone ScrewJeil Medical CorporationLXT2021-11-18
08800089416622INLET System Bone ScrewJeil Medical CorporationLXT2021-11-18
08800089416639INLET System Bone ScrewJeil Medical CorporationLXT2021-11-18
08800089416646INLET System Bone ScrewJeil Medical CorporationLXT2021-11-18
08800089416653INLET System Bone ScrewJeil Medical CorporationLXT2021-11-18
08800089416660INLET System Bone ScrewJeil Medical CorporationLXT2021-11-18
08800089416677INLET System Bone ScrewJeil Medical CorporationLXT2021-11-18
08800089416684INLET System Bone ScrewJeil Medical CorporationLXT2021-11-18
10381780065197Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065203Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065210Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065227Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065234Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065241Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065258Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065265Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065272Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065289Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065296Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065302Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065319Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065326Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065333Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065340Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065357Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065364Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09
10381780065371Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.LXT2017-10-09