FDA.reportPublic FDA data

SOLOFIX Provisional Fixation System

Primary DI
00850083430122
Brand
SOLOFIX Provisional Fixation System
Company
AXIA ORTHOPEDICS, INC.
Model
500-107
Device description
2.4MM (.094”) K-WIRE WITH 15MM THREADED-TROCAR POINT, 229MM (9”)
Published
2026-08-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850083430122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850083430122008500834301228500834301220850083430122

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic intraoperative positioning pin, single-useA nonimplantable device in the form of a thin rod intended to be drilled into bone to assist with the positioning of an implantable device and/or surgical instrument (e.g., fixation plate, drill guide) during an orthopaedic procedure. It is also referred to as a wire or temporary K-wire. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Outer Diameter0

Contacts#

Phone, Email table
PhoneEmail
503-217-4226customerservice@axiaortho.com

Regulatory Flags#

DUNS number
144832221
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850083430009SOLOFIX Provisional Fixation System500-1012026-08-17
00850083430047SOLOFIX Provisional Fixation System500-1022026-08-17
00850083430061SOLOFIX Provisional Fixation System500-1052026-08-17
00850083430078SOLOFIX Provisional Fixation System500-1032026-08-17
00850083430092SOLOFIX Provisional Fixation System500-1042026-08-17
00850083430108SOLOFIX Provisional Fixation System500-1062026-08-17
00850083430139SOLOFIX Provisional Fixation System500-1082026-08-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850078396372PFT Adapter, DS, Virata, 85 in-lb (228-TXRX-008)Eca Medical InstrumentsHWE2026-10-20
00889024709164CANNULATED 1.5MM HEX DRIVERZimmer, Inc.HWE2026-10-19
00889024709171CANNULATED 2.0MM HEX DRIVERZimmer, Inc.HWE2026-10-19
00810111227872PinTreace Medical Concepts, Inc.HWE2026-10-16
00763000786458CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-15
00810111228541Drill TackTreace Medical Concepts, Inc.HWE2026-10-15
00810111227971PinTreace Medical Concepts, Inc.HWE2026-10-12
00810111227988PinTreace Medical Concepts, Inc.HWE2026-10-12
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08800038061286EZXIMEDICOM CO., LTD.HWE2026-08-25
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00850083430139SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWE2026-08-17
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