INTREPED, Intraosseous Fusion Device 01-40608

GUDID 00850055649378

INTREPED 08 Tap (Beta)

Auxano Medical LLC

Orthopaedic bone screw (non-sliding)

• Primary Device ID: 00850055649378
• NIH Device Record Key: 95b22f9c-26f7-470c-ae8a-9069ca45e83e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTREPED, Intraosseous Fusion Device
• Version Model Number: 01-40608
• Catalog Number: 01-40608
• 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: false
• 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

Customer Support Contacts

• Phone: 4402622000
• Email: CS@AuxanoMedical.net
• Phone: 4402622000
• Email: CS@AuxanoMedical.net
• Phone: 4402622000
• Email: CS@AuxanoMedical.net
• Phone: 4402622000
• Email: CS@AuxanoMedical.net
• Phone: 4402622000
• Email: CS@AuxanoMedical.net
• Phone: 4402622000
• Email: CS@AuxanoMedical.net
• Phone: 4402622000
• Email: CS@AuxanoMedical.net
• Phone: 4402622000
• Email: CS@AuxanoMedical.net
• Phone: 4402622000
• Email: CS@AuxanoMedical.net
• Phone: 4402622000
• Email: CS@AuxanoMedical.net
• Phone: 4402622000
• Email: CS@AuxanoMedical.net
• Phone: 4402622000
• Email: CS@AuxanoMedical.net
• Phone: 4402622000
• Email: CS@AuxanoMedical.net
• Phone: 4402622000
• Email: CS@AuxanoMedical.net
• Phone: 4402622000
• Email: CS@AuxanoMedical.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850055649378 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231649

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00850055649378]

Moist Heat or Steam Sterilization

[00850055649378]

Moist Heat or Steam Sterilization

[00850055649378]

Moist Heat or Steam Sterilization

[00850055649378]

Moist Heat or Steam Sterilization

[00850055649378]

Moist Heat or Steam Sterilization

[00850055649378]

Moist Heat or Steam Sterilization

[00850055649378]

Moist Heat or Steam Sterilization

[00850055649378]

Moist Heat or Steam Sterilization

[00850055649378]

Moist Heat or Steam Sterilization

[00850055649378]

Moist Heat or Steam Sterilization

[00850055649378]

Moist Heat or Steam Sterilization

[00850055649378]

Moist Heat or Steam Sterilization

[00850055649378]

Moist Heat or Steam Sterilization

[00850055649378]

Moist Heat or Steam Sterilization

[00850055649378]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-01
• Device Publish Date: 2025-03-24

On-Brand Devices [INTREPED, Intraosseous Fusion Device]

• 00850055649255: The INTREPED, Intraosseous Fusion Device (IFD) System includes implants, instruments and tray co
• 00850055649248: INTREPED Axial-Handle
• 00850055649231: INTREPED T-Handle
• 00850055649224: INTREPED 1.6x6 K-wire
• 00850055649217: INTREPED Spanner Drive
• 00850055649200: INTREPED 12 Sizer
• 00850055649194: INTREPED 09 Sizer
• 00850055649187: INTREPED 06 Sizer
• 00850055649170: INTREPED 12 Driver
• 00850055649163: INTREPED 09 Driver
• 00850055649156: INTREPED 06 Driver
• 00850055649149: INTREPED 12 Tap
• 00850055649132: INTREPED 09 Tap
• 00850055649125: INTREPED 06 Tap
• 00850055649118: INTREPED 12 Drill
• 00850055649101: INTREPED 09 Drill
• 00850055649095: INTREPED 06 Drill
• 00850055649088: INTREPED 12x20 implant
• 00850055649071: INTREPED 12x15 implant
• 00850055649064: INTREPED 12x10 implant
• 00850055649057: INTREPED 09x20 implant
• 00850055649040: INTREPED 09x15 implant
• 00850055649033: INTREPED 09x10 implant
• 00850055649026: INTREPED 06x20 implant
• 00850055649019: INTREPED 06x15 implant
• 00850055649002: INTREPED 06x10 implant
• 00850055649699: The INTREPED, Intraosseous Fusion Device TMT (IFD) System- 10mm Caddy Kit includes implants, ins
• 00850055649682: The INTREPED, Intraosseous Fusion Device TMT (IFD) System- 9mm Caddy Kit includes implants, inst
• 00850055649675: The INTREPED, Intraosseous Fusion Device TMT (IFD) System- 8mm Caddy Kit includes implants, inst
• 00850055649668: The INTREPED, Intraosseous Fusion Device TMT (IFD) System includes implants, instruments and tra
• 00850055649651: INTREPED 10 Universal Depth Stop
• 00850055649644: INTREPED 09 Universal Depth Stop
• 00850055649637: INTREPED 08 Universal Depth Stop
• 00850055649620: INTREPED K-Wire Depth Gauge
• 00850055649613: INTREPED 1.6x4 K-wire
• 00850055649606: INTREPED 10 Drill- Universal Stop
• 00850055649590: INTREPED 08 Drill- Universal Stop
• 00850055649583: INTREPED 09 Drill- Universal Stop
• 00850055649576: INTREPED 10x14 implant
• 00850055649569: INTREPED 10x12 implant
• 00850055649552: INTREPED 10x10 implant
• 00850055649545: INTREPED 08x14 implant
• 00850055649538: INTREPED 08x12 implant
• 00850055649521: INTREPED 08x10 implant
• 00850055649514: INTREPED 09x14 implant
• 00850055649507: INTREPED 09x12 implant
• 00850055649491: INTREPED TMT Tray System
• 00850055649484: INTREPED TMT Tray System- 08 Caddy Assy
• 00850055649477: INTREPED TMT Tray System- 09 Caddy Assy
• 00850055649460: INTREPED TMT Tray System- 10 Caddy Assy