RAVEN

GUDID 00840996184083

RAVEN,5.0X55

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840996184083
• NIH Device Record Key: 1d13f9e7-b041-47a4-8b95-640bbefd0161
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RAVEN
• Version Model Number: YT35-5055
• 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: true
• 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(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840996184083 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191367

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00840996184083]

Moist Heat or Steam Sterilization

[00840996184083]

Moist Heat or Steam Sterilization

[00840996184083]

Moist Heat or Steam Sterilization

[00840996184083]

Moist Heat or Steam Sterilization

[00840996184083]

Moist Heat or Steam Sterilization

[00840996184083]

Moist Heat or Steam Sterilization

[00840996184083]

Moist Heat or Steam Sterilization

[00840996184083]

Moist Heat or Steam Sterilization

[00840996184083]

Moist Heat or Steam Sterilization

[00840996184083]

Moist Heat or Steam Sterilization

[00840996184083]

Moist Heat or Steam Sterilization

[00840996184083]

Moist Heat or Steam Sterilization

[00840996184083]

Moist Heat or Steam Sterilization

[00840996184083]

Moist Heat or Steam Sterilization

[00840996184083]

Moist Heat or Steam Sterilization

[00840996184083]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-13
• Device Publish Date: 2023-02-03

On-Brand Devices [RAVEN]

• 00840996184137: RAVEN,5.5X60
• 00840996184120: RAVEN,5.5X55
• 00840996184113: RAVEN,5.5X45
• 00840996184106: RAVEN,5.5X50
• 00840996184090: RAVEN,5.0X60
• 00840996184083: RAVEN,5.0X55
• 00840996184076: RAVEN,5.0X50
• 00840996184069: RAVEN,5.0X45