FDA.reportPublic FDA data

NuFix II

Primary DI
B946021000010
Brand
NuFix II
Company
Nutech Spine, Inc.
Model
IR
Catalog number
02.100.001
Device description
NuFix II Go/No-Go Gage
Published
2020-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B946021000010PrimaryHIBCC0

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

Regulatory Flags#

DUNS number
080867996
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B946NF10050NuFixIRNF-10052020-09-24
B946NFII5000NuFix II01NFII-5002020-09-24
B946NFII500IR0NuFix IIIRNFII-5002020-09-24
B946011000010NuFix0401.100.0012024-07-15
B946007020010SIFixIR00.702.0012023-11-16
B946037000020SIFix0103.700.0022023-11-16
B946NF10090NuFixIRNF-10092020-09-24
B946008010040NuTech SpineIR00.801.0042020-09-24
B946014000010NuFix0101.400.0012020-09-24
B946024000010NuFix IIIR02.400.0012020-09-24
B946024000030NuFix IIIR02.400.0032020-09-24
B946024000040NuFix IIIR02.400.0042020-09-24
B946024000050NuFix IIIR02.400.0052020-09-24
B946024000060NuFix IIIR02.400.0062020-09-24
B946024000070NuFix IIIR02.400.0072020-09-24
B946031000020SIFix0103.100.0022020-09-24
B946031002600SIFix0103.100.2602020-09-24
B946031100010SIFix0103.110.0012020-09-24
B946032000010SIFix0103.200.0012020-09-24
B946032000020SIFix0103.200.0022020-09-24

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