Navigation 161-0010

GUDID M7401610010

Navigation Awl

SPINEOLOGY INC.

Stereotactic surgery system probe, reusable

• Primary Device ID: M7401610010
• NIH Device Record Key: c3720cc6-056f-4983-a6d3-646cb5260964
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Navigation
• Version Model Number: 16-04-01
• Catalog Number: 161-0010
• Company DUNS: 033014361
• Company Name: SPINEOLOGY INC.
• 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: false
• 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: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M7401610010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180796

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

[M7401610010]

Moist Heat or Steam Sterilization

[M7401610010]

Moist Heat or Steam Sterilization

[M7401610010]

Moist Heat or Steam Sterilization

[M7401610010]

Moist Heat or Steam Sterilization

[M7401610010]

Moist Heat or Steam Sterilization

[M7401610010]

Moist Heat or Steam Sterilization

[M7401610010]

Moist Heat or Steam Sterilization

[M7401610010]

Moist Heat or Steam Sterilization

[M7401610010]

Moist Heat or Steam Sterilization

[M7401610010]

Moist Heat or Steam Sterilization

[M7401610010]

Moist Heat or Steam Sterilization

[M7401610010]

Moist Heat or Steam Sterilization

[M7401610010]

Moist Heat or Steam Sterilization

[M7401610010]

Moist Heat or Steam Sterilization

[M7401610010]

Moist Heat or Steam Sterilization

[M7401610010]

Moist Heat or Steam Sterilization

[M7401610010]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-07-22
• Device Publish Date: 2018-08-28

On-Brand Devices [Navigation]

• M7401610015: Awl Stylet
• M7401610026: Screwdriver, Fortress
• M7401610025: Screwdriver, Palisade
• M7401610023: Solid Tap, 7.5
• M7401610022: Solid Tap, 6.5
• M7401610021: Solid Tap, 5.5
• M7401610020: Solid Tap, 4.5
• M7401610017: Cannulated Navigation Awl
• M7401610012: Screwdriver, Threshold
• M7401610010: Navigation Awl
• M7401610009: Drill, 6.5
• M7401610008: Drill, 5.5
• M7401610007: Drill, 4.5
• M7401610006: Drill, 3.5
• M7401610005: Cannulated Tap, 7.5
• M7401610004: Cannulated Tap, 6.5
• M7401610003: Cannulated Tap, 5.5
• M7401610002: Cannulated Tap, 4.5