FDA.reportPublic FDA data

NanoPhix Implant

Primary DI
B487EXINN9215190
Brand
NanoPhix Implant
Company
Exsomed Corporation
Model
EXINN921519
Catalog number
EXINN921519
Device description
NanoPhix is a stainless steel bone screw.
Published
2022-11-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B487EXINN9215190PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended to be used for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, or used in dentistry/orthodontics, craniofacial or spinal bones. It is typically of cortical or cancellous design and has a drive (e.g., a slot, or of cross, star, or polygonal shape) at its proximal end for introduction with a screwdriver. It is made of non-bioabsorbable materials (e.g., metal).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length19Millimeter
Outer Diameter1.5Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
116722111
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B487EXINN9215060NanoPhix ImplantEXINN921506EXINN9215062022-11-01
B487EXINN9215070NanoPhix ImplantEXINN921507EXINN9215072022-11-01
B487EXINN9215080NanoPhix ImplantEXINN921508EXINN9215082022-11-01
B487EXINN9215090NanoPhix ImplantEXINN921509EXINN9215092022-11-01
B487EXINN9215100NanoPhix ImplantEXINN921510EXINN9215102022-11-01
B487EXINN9215110NanoPhix ImplantEXINN921511EXINN9215112022-11-01
B487EXINN9215120NanoPhix ImplantEXINN921512EXINN9215122022-11-01
B487EXINN9215130NanoPhix ImplantEXINN921513EXINN9215132022-11-01
B487EXINN9215140NanoPhix ImplantEXINN921514EXINN9215142022-11-01
B487EXINN9215150NanoPhix ImplantEXINN921515EXINN9215152022-11-01
B487EXINN9215160NanoPhix ImplantEXINN921516EXINN9215162022-11-01
B487EXINN9215170NanoPhix ImplantEXINN921517EXINN9215172022-11-01
B487EXINN9215180NanoPhix ImplantEXINN921518EXINN9215182022-11-01
B487EXINN9215200NanoPhix ImplantEXINN921520EXINN9215202022-11-01
B487EXINN9215210NanoPhix ImplantEXINN921521EXINN9215212022-11-01
B487EXINN9215220NanoPhix ImplantEXINN921522EXINN9215222022-11-01
B487EXINN9215230NanoPhix ImplantEXINN921523EXINN9215232022-11-01
B487EXINN9215240NanoPhix ImplantEXINN921524EXINN9215242022-11-01
B487EXINN9215250NanoPhix ImplantEXINN921525EXINN9215252022-11-01
B487EXINN9215260NanoPhix ImplantEXINN921526EXINN9215262022-11-01

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