FDA.reportPublic FDA data

INTREPED, Intraosseous Fusion Device

Primary DI
00850055649408
Brand
INTREPED, Intraosseous Fusion Device
Company
Auxano Medical LLC
Model
01-40208
Catalog number
01-40208
Device description
INTREPED 08 Driver
Published
2025-03-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231649000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231649000Intraosseous Fusion Device SystemAuxano Medical, LLC2023-09-29HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850055649408PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850055649408008500556494088500556494080850055649408

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended 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, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
4402622000CS@AuxanoMedical.net

Regulatory Flags#

DUNS number
119185571
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810199190006ARKEO, Wedge Fixation System02-5166502-516652025-11-24
00810199190013ARKEO, Wedge Fixation System02-5204502-520452025-11-24
00810199190020ARKEO, Wedge Fixation System02-5205502-520552025-11-24
00810199190037ARKEO, Wedge Fixation System02-5206502-520652025-11-24
00810199190044ARKEO, Wedge Fixation System02-4000102-400012025-11-24
00810199190051ARKEO, Wedge Fixation System02-4000302-400032025-11-24
00810199190068ARKEO, Wedge Fixation System02-4000402-400042025-11-24
00810199190075ARKEO, Wedge Fixation System02-4000502-400052025-11-24
00810199190082ARKEO, Wedge Fixation System02-4000602-400062025-11-24
00810199190099ARKEO, Wedge Fixation System02-4001002-400102025-11-24
00810199190105ARKEO, Wedge Fixation System02-4001202-400122025-11-24
00810199190112ARKEO, Wedge Fixation System02-4016402-401642025-11-24
00810199190129ARKEO, Wedge Fixation System02-7000102-700012025-11-24
00810199190136ARKEO, Wedge Fixation System02-7000202-700022025-11-24
00810199190143ARKEO, Wedge Fixation System02-7000302-700032025-11-24
00810199190150ARKEO, Wedge Fixation System02-0000102-000012025-11-24
00810199190211ARKEO, Wedge Fixation System02-0000302-000032025-11-24
00850055649712ARKEO, Wedge Fixation System02-4000202-400022025-11-24
00850055649736ARKEO, Wedge Fixation System02-4000702-400072025-11-24
00850055649743ARKEO, Wedge Fixation System02-1180802-118082025-11-24

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Primary DI, Brand, Company table
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