Octane M

GUDID 00840996153492

OCTANE M,INSERTER RAIL

Choice Spine, LP

Polymeric spinal interbody fusion cage

• Primary Device ID: 00840996153492
• NIH Device Record Key: 5499982b-489e-4920-878d-1b5720d8805c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Octane M
• Version Model Number: 05-049-04-0000
• Company DUNS: 078293017
• Company Name: Choice Spine, LP
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840996153492 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123607

FDA Product Code

• LXH: Orthopedic manual surgical instrument

Sterilization

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

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

[00840996153492]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-04
• Device Publish Date: 2024-02-24

On-Brand Devices [Octane M]

• 00840996153607: OCTANE M,IMPACTION CAP
• 00840996153591: OCTANE M,ANGLED POSITIONER
• 00840996153584: OCTANE M,STRAIGHT POSITIONER
• 00840996153577: OCTANE M,GRAFT PUSHER
• 00840996153560: OCTANE M, GRAFT TUBE
• 00840996153539: OCTANE M,RAIL SHAFT,24MM
• 00840996153522: OCTANE M,RAIL SHAFT,26MM
• 00840996153515: OCTANE M,RAIL SHAFTS
• 00840996153508: OCTANE M,GEAR INSERTER HANDLE
• 00840996153492: OCTANE M,INSERTER RAIL
• 00840996153485: OCTANE M,GEAR INSERTER,24MM
• 00840996153478: OCTANE M,GEAR INSERTER,26MM
• 00840996153461: OCTANE M,GEAR DRIVE INSERTER
• 00840996153454: OCTANE M,RATCHET INSERTER HANDLE