Spineology Navigation Instruments 161-0033

GUDID M7401610033

Navigation Adapter

SPINEOLOGY INC.

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: M7401610033
• NIH Device Record Key: a66fe45f-2a0c-45a6-ad94-f034ac1b3b06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spineology Navigation Instruments
• Version Model Number: 16-08-01
• Catalog Number: 161-0033
• Company DUNS: 033014361
• Company Name: SPINEOLOGY INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: 6512568500
• Email: info@spineology.com
• Phone: 6512568500
• Email: info@spineology.com
• Phone: 6512568500
• Email: info@spineology.com
• Phone: 6512568500
• Email: info@spineology.com
• Phone: 6512568500
• Email: info@spineology.com
• Phone: 6512568500
• Email: info@spineology.com
• Phone: 6512568500
• Email: info@spineology.com
• Phone: 6512568500
• Email: info@spineology.com
• Phone: 6512568500
• Email: info@spineology.com
• Phone: 6512568500
• Email: info@spineology.com
• Phone: 6512568500
• Email: info@spineology.com
• Phone: 6512568500
• Email: info@spineology.com
• Phone: 6512568500
• Email: info@spineology.com
• Phone: 6512568500
• Email: info@spineology.com
• Phone: 6512568500
• Email: info@spineology.com
• Phone: 6512568500
• Email: info@spineology.com
• Phone: 6512568500
• Email: info@spineology.com
• Phone: 6512568500
• Email: info@spineology.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M7401610033 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182345

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[M7401610033]

Moist Heat or Steam Sterilization

[M7401610033]

Moist Heat or Steam Sterilization

[M7401610033]

Moist Heat or Steam Sterilization

[M7401610033]

Moist Heat or Steam Sterilization

[M7401610033]

Moist Heat or Steam Sterilization

[M7401610033]

Moist Heat or Steam Sterilization

[M7401610033]

Moist Heat or Steam Sterilization

[M7401610033]

Moist Heat or Steam Sterilization

[M7401610033]

Moist Heat or Steam Sterilization

[M7401610033]

Moist Heat or Steam Sterilization

[M7401610033]

Moist Heat or Steam Sterilization

[M7401610033]

Moist Heat or Steam Sterilization

[M7401610033]

Moist Heat or Steam Sterilization

[M7401610033]

Moist Heat or Steam Sterilization

[M7401610033]

Moist Heat or Steam Sterilization

[M7401610033]

Moist Heat or Steam Sterilization

[M7401610033]

Moist Heat or Steam Sterilization

[M7401610033]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-05-03
• Device Publish Date: 2018-09-24

Devices Manufactured by SPINEOLOGY INC.

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• M7401001308 - Rampart One Lumbar Interbody Fusion System: 2025-04-29 Trial 10.5mm S 8°
• M7401001309 - Rampart One Lumbar Interbody Fusion System: 2025-04-29 Trial 12mm S 8°
• M7401001310 - Rampart One Lumbar Interbody Fusion System: 2025-04-29 Trial 14mm S 8°
• M7401001311 - Rampart One Lumbar Interbody Fusion System: 2025-04-29 Trial 12mm S 12°
• M7401001312 - Rampart One Lumbar Interbody Fusion System: 2025-04-29 Trial 14mm S 12°
• M7401001313 - Rampart One Lumbar Interbody Fusion System: 2025-04-29 Trial 10.5mm M 8°