| Primary Device ID | 00850055649774 |
| NIH Device Record Key | 2331c613-a0b5-4781-a6b2-a22219ad2b61 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ARKEO, Wedge Fixation System |
| Version Model Number | 02-12008 |
| Catalog Number | 02-12008 |
| Company DUNS | 119185571 |
| Company Name | Auxano Medical LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 4402622000 |
| CS@AuxanoMedical.net | |
| Phone | 4402622000 |
| CS@AuxanoMedical.net | |
| Phone | 4402622000 |
| CS@AuxanoMedical.net | |
| Phone | 4402622000 |
| CS@AuxanoMedical.net | |
| Phone | 4402622000 |
| CS@AuxanoMedical.net | |
| Phone | 4402622000 |
| CS@AuxanoMedical.net | |
| Phone | 4402622000 |
| CS@AuxanoMedical.net | |
| Phone | 4402622000 |
| CS@AuxanoMedical.net | |
| Phone | 4402622000 |
| CS@AuxanoMedical.net | |
| Phone | 4402622000 |
| CS@AuxanoMedical.net | |
| Phone | 4402622000 |
| CS@AuxanoMedical.net |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850055649774 [Primary] |
| PLF | Bone Wedge |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00850055649774]
Moist Heat or Steam Sterilization
[00850055649774]
Moist Heat or Steam Sterilization
[00850055649774]
Moist Heat or Steam Sterilization
[00850055649774]
Moist Heat or Steam Sterilization
[00850055649774]
Moist Heat or Steam Sterilization
[00850055649774]
Moist Heat or Steam Sterilization
[00850055649774]
Moist Heat or Steam Sterilization
[00850055649774]
Moist Heat or Steam Sterilization
[00850055649774]
Moist Heat or Steam Sterilization
[00850055649774]
Moist Heat or Steam Sterilization
[00850055649774]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-02 |
| Device Publish Date | 2025-11-24 |
| 00850055649996 | ARKEO Cotton Wedge Trial, 16x11x5.5 |
| 00850055649989 | ARKEO Cotton Wedge Trial, 16x11x4.5 |
| 00850055649972 | ARKEO Evan's Wedge Trial, 22x22x12 |
| 00850055649965 | ARKEO Evan's Wedge Trial, 22x22x10 |
| 00850055649958 | ARKEO Evan's Wedge Trial, 22x22x08 |
| 00850055649941 | ARKEO Evan's Wedge Trial, 20x20x12 |
| 00850055649934 | ARKEO Evan's Wedge Trial, 20x20x10 |
| 00850055649927 | ARKEO Evan's Wedge Trial, 20x20x08 |
| 00850055649910 | ARKEO Evan's Wedge Trial, 18x18x12 |
| 00850055649903 | ARKEO Evan's Wedge Trial, 18x18x10 |
| 00850055649897 | ARKEO Evan's Wedge Trial, 18x18x08 |
| 00850055649880 | ARKEO Cotton Wedge, 20x14x6.5 |
| 00850055649873 | ARKEO Cotton Wedge, 20x14x5.5 |
| 00850055649866 | ARKEO Cotton Wedge, 20x14x4.5 |
| 00850055649859 | ARKEO Cotton Wedge, 16x11x6.5 |
| 00850055649842 | ARKEO Cotton Wedge, 16x11x5.5 |
| 00850055649835 | ARKEO Cotton Wedge, 16x11x4.5 |
| 00850055649828 | ARKEO Evan's Wedge, 22x22x12 |
| 00850055649811 | ARKEO Evan's Wedge, 22x22x10 |
| 00850055649804 | ARKEO Evan's Wedge, 22x22x08 |
| 00850055649798 | ARKEO Evan's Wedge, 20x20x12 |
| 00850055649781 | ARKEO Evan's Wedge, 20x20x10 |
| 00850055649774 | ARKEO Evan's Wedge, 20x20x08 |
| 00850055649767 | ARKEO Evan's Wedge, 18x18x12 |
| 00850055649750 | ARKEO Evan's Wedge, 18x18x10 |
| 00850055649743 | ARKEO Evan's Wedge, 18x18x08 |
| 00850055649736 | ARKEO Wedge Slap Hammer Assy |
| 00850055649712 | ARKEO Wedge Draw Rod Assy |
| 00810199190211 | The ARKEO Wedge Fixation System (Preliminary Kit-2) includes implants, instruments and tray comp |
| 00810199190150 | The ARKEO Wedge Fixation System includes implants, instruments and tray components. |
| 00810199190143 | ARKEO Wedge Tray System- Cotton Wedge Caddy Assy |
| 00810199190136 | ARKEO Wedge Tray System- Evan's Wedge Caddy Assy |
| 00810199190129 | ARKEO Wedge Tray System |
| 00810199190112 | ARKEO Smooth K-Wire, 1.6x4 |
| 00810199190105 | ARKEO Osteotome- 12mm |
| 00810199190099 | ARKEO Osteotome- 10mm |
| 00810199190082 | ARKEO Osteotome- 6mm |
| 00810199190075 | ARKEO Mallet |
| 00810199190068 | ARKEO Hintermann Distractor |
| 00810199190051 | ARKEO Wedge Impactor |
| 00810199190044 | ARKEO Wedge Inserter Handle |
| 00810199190037 | ARKEO Cotton Wedge Trial, 20x14x6.5 |
| 00810199190020 | ARKEO Cotton Wedge Trial, 20x14x5.5 |
| 00810199190013 | ARKEO Cotton Wedge Trial, 20x14x4.5 |
| 00810199190006 | ARKEO Cotton Wedge Trial, 16x11x6.5 |