HARPOON LUMBAR SPACER SYSTEM

GUDID 00840996181853

PLI,SPACER,HARPOON,36X9, 4 DEG

Choice Spine, LP

Polymeric spinal interbody fusion cage

• Primary Device ID: 00840996181853
• NIH Device Record Key: 8ae1d5db-6de6-4485-834e-3c82f7bbad81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HARPOON LUMBAR SPACER SYSTEM
• Version Model Number: PP40-36094
• 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	00840996181853 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140142

FDA Product Code

• MQP: Spinal vertebral body replacement device

Sterilization

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

[00840996181853]

Moist Heat or Steam Sterilization

[00840996181853]

Moist Heat or Steam Sterilization

[00840996181853]

Moist Heat or Steam Sterilization

[00840996181853]

Moist Heat or Steam Sterilization

[00840996181853]

Moist Heat or Steam Sterilization

[00840996181853]

Moist Heat or Steam Sterilization

[00840996181853]

Moist Heat or Steam Sterilization

[00840996181853]

Moist Heat or Steam Sterilization

[00840996181853]

Moist Heat or Steam Sterilization

[00840996181853]

Moist Heat or Steam Sterilization

[00840996181853]

Moist Heat or Steam Sterilization

[00840996181853]

Moist Heat or Steam Sterilization

[00840996181853]

Moist Heat or Steam Sterilization

[00840996181853]

Moist Heat or Steam Sterilization

[00840996181853]

Moist Heat or Steam Sterilization

[00840996181853]

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 [HARPOON LUMBAR SPACER SYSTEM]

• 00840996148214: PLI,SPACER,HARPOON,36X10,4 DEG
• 00840996148207: PLI,SPACER,HARPOON,36X12,4 DEG
• 00840996148191: PLI,SPACER,HARPOON,36X13,4 DEG
• 00840996181853: PLI,SPACER,HARPOON,36X9, 4 DEG
• 00840996181846: PLI,SPACER,HARPOON,36X14,4 DEG