FDA.reportPublic FDA data

ARKEO, Wedge Fixation System

Primary DI
00810199190020
Brand
ARKEO, Wedge Fixation System
Company
Auxano Medical LLC
Model
02-52055
Catalog number
02-52055
Device description
ARKEO Cotton Wedge Trial, 20x14x5.5
Published
2025-11-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PLFBone Wedge

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PLFBone WedgeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251791000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251791000Auxano® Wedge Fixation SystemAuxano Medical, LLC2025-09-25PLF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810199190020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810199190020008101991900208101991900200810199190020

GMDN Terms#

Term, Definition table
TermDefinition
Metallic osteotomy fusion cage, non-customized A non-customized device intended to be implanted between the severed ends of a long bone (e.g., femur, tibia), or other bone (e.g., tarsal, carpel), following osteotomy to help facilitate bone fusion and alignment; it may be used with a plating fixation system and may be used in association with a bone substitute/graft. The device is typically designed as a small, wedge-shaped cylinder (or other geometric form) and is made of metal [e.g., titanium (Ti)].

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
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
00850055649750ARKEO, Wedge Fixation System02-1181002-118102025-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G817103151100SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G817103151200SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325121605SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325121606SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325121607SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325121608SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325121610SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325121612SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325141805SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325141806SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325141807SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325141808SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325141810SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325141812SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G817S101181806SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G817S111121605SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111121606SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111121607SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111121608SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111121610SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111121612SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111141805SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111141806SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111141807SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111141808SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111141810SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111141812SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
00810199190006ARKEO, Wedge Fixation SystemAuxano Medical LLCPLF2025-11-24
00810199190013ARKEO, Wedge Fixation SystemAuxano Medical LLCPLF2025-11-24
00810199190037ARKEO, Wedge Fixation SystemAuxano Medical LLCPLF2025-11-24