FDA.reportPublic FDA data

SOLOFIX Provisional Fixation System

Primary DI
00850083430047
Brand
SOLOFIX Provisional Fixation System
Company
AXIA ORTHOPEDICS, INC.
Model
500-102
Device description
2.4MM (.094”) WIRE LOCK
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

Product Codes#

Code, Name table
CodeName
HWNInstrument, Compression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWNInstrument, CompressionOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850083430054PackageGS15In Commercial Distribution
00850083430047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850083430054008500834300548500834300540850083430054
00850083430047008500834300478500834300470850083430047

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Outer Diameter0

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
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
00850083430122SOLOFIX Provisional Fixation System500-1072026-08-17
00850083430139SOLOFIX Provisional Fixation System500-1082026-08-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10886982357335VOLTSynthes GmbHHWN2026-09-25
10886982357342VOLTSynthes GmbHHWN2026-09-25
10886982357359VOLTSynthes GmbHHWN2026-09-25
10886982357366VOLTSynthes GmbHHWN2026-09-25
10886982357373VOLTSynthes GmbHHWN2026-09-25
10886982357380VOLTSynthes GmbHHWN2026-09-25
10886982357397VOLTSynthes GmbHHWN2026-09-25
10886982357403VOLTSynthes GmbHHWN2026-09-25
10886982357410VOLTSynthes GmbHHWN2026-09-25
10886982357427VOLTSynthes GmbHHWN2026-09-25
10886982357434VOLTSynthes GmbHHWN2026-09-25
10886982357441VOLTSynthes GmbHHWN2026-09-25
10886982357458VOLTSynthes GmbHHWN2026-09-25
10886982357465VOLTSynthes GmbHHWN2026-09-25
10886982357472VOLTSynthes GmbHHWN2026-09-25
10886982357489VOLTSynthes GmbHHWN2026-09-25
10886982357823VOLTSynthes GmbHHWN2026-09-25
10886982357830VOLTSynthes GmbHHWN2026-09-25
00850083430009SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWN2026-08-17
00850083430078SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWN2026-08-17
00850083430092SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWN2026-08-17
00810111228374Positioner / CompressorTreace Medical Concepts, Inc.HWN2026-07-17
00810111228381Positioner / CompressorTreace Medical Concepts, Inc.HWN2026-07-17
00840311251148Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-30
00840311251155Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-30
00840311251162Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-30
00840311251179Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-30
00840311251377Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-30
00840311262953Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-27
00810111225281Instrument TrayTreace Medical Concepts, Inc.HWN2026-03-30