FDA.reportPublic FDA data

AUXANO MEDICAL LLC

Matched from indexed company URL: Auxano Medical LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30302710543030271054AUXANO MEDICAL LLC1N2026-01-018006 Katherine Boulevard Brecksville OH US 44141

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00810199190006ARKEO, Wedge Fixation System - ARKEO Cotton Wedge Trial, 16x11x6.54402622000CS@AuxanoMedical.net
00810199190013ARKEO, Wedge Fixation System - ARKEO Cotton Wedge Trial, 20x14x4.54402622000CS@AuxanoMedical.net
00810199190020ARKEO, Wedge Fixation System - ARKEO Cotton Wedge Trial, 20x14x5.54402622000CS@AuxanoMedical.net
00810199190037ARKEO, Wedge Fixation System - ARKEO Cotton Wedge Trial, 20x14x6.54402622000CS@AuxanoMedical.net

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3246961883782212K251791Auxano® Wedge Fixation SystemPLF2025-09-25
3246961774965338K231649Intraosseous Fusion Device SystemHWC2023-09-29
3246961430140993

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PLF12025-09-25
HWC12023-09-29

PMN#

GUDID#

106 records. Showing 1-40. Next