FDA.reportPublic FDA data

ArcPhix System

Primary DI
B487EXARC9030280
Brand
ArcPhix System
Company
Exsomed Corporation
Model
EXARC903028
Catalog number
EXARC903028
Device description
ArcPhix Compression Screw SystemThe system includes the implant, two guide wires, one cannulated drill, and a driver.
Published
2018-04-06
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
HTWBit, Drill
HWCScrew, Fixation, Bone
HXIPasser, Wire, Orthopedic
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1
HWCScrew, Fixation, BoneOrthopedic2
HXIPasser, Wire, OrthopedicOrthopedic1
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B487EXARC9030280PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant driverA hand-held manual surgical instrument designed to impart force to an orthopaedic implantable device that is inserted to fix or fasten together bones. The device is frequently used to insert devices such as screws, nails, plates, or wires that are used to fix fractured or damaged bones and/or to attach orthopaedic prostheses to the bones. It is typically made of high-grade stainless steel or titanium (Ti). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length28Millimeter
Outer Diameter3Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
116722111
Device count
1
Kit
true
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
B487EXINN9215190NanoPhix ImplantEXINN921519EXINN9215192022-11-01
B487EXINN9215200NanoPhix ImplantEXINN921520EXINN9215202022-11-01
B487EXINN9215210NanoPhix ImplantEXINN921521EXINN9215212022-11-01
B487EXINN9215220NanoPhix ImplantEXINN921522EXINN9215222022-11-01
B487EXINN9215230NanoPhix ImplantEXINN921523EXINN9215232022-11-01
B487EXINN9215240NanoPhix ImplantEXINN921524EXINN9215242022-11-01
B487EXINN9215250NanoPhix ImplantEXINN921525EXINN9215252022-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776404192MillenniumAvalign Technologies, Inc.LXH2026-07-24
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00196449002573LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002580LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002597LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002603LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002610LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
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00196449002641LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
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00196449002672LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002689LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002696LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002702LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002719LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002726LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002733LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002740LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002757LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002764LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002771LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002788LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002795LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08