FDA.reportPublic FDA data

HEX-FIX

Primary DI
03596010042323
Brand
HEX-FIX
Company
Smith & Nephew, Inc.
Model
112720
Catalog number
112720
Device description
HEX-FIX DEPTH GAUGE
Published
2017-11-13
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
03596010042323PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010042323035960100423233596010042323

GMDN Terms#

Term, Definition table
TermDefinition
Surgical depth gauge, reusableA surgical instrument designed to measure the depth of a recess, usually to measure the depth of holes being drilled in bone so that the surgeon can determine the length of the bone screw to be used. It may take two forms: 1) a device with a moveable (sliding) centrepiece (a prong), the tip of which is inserted into the recess to read from a scale; 2) a circular disc with a central hole which is clipped to a drill bit so that the device slides up as the drill bit is advanced. This is a reusable device intended to be sterilized prior to use.

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
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
03596010544230JOURNEY71461016714610162015-08-30

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