Lumbar Spacer System (SABRE, SHARK, HORNET, HARPOON)

GUDID 00840996148108

PLI,SPCL,MALLET,PANCAKE

Choice Spine, LP

Polymeric spinal interbody fusion cage

• Primary Device ID: 00840996148108
• NIH Device Record Key: a1a66511-a21e-44a7-ad96-3bf5b4f334a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lumbar Spacer System (SABRE, SHARK, HORNET, HARPOON)
• Version Model Number: SPCL-P086
• 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

Customer Support Contacts

• Phone: +1(865)246-3333
• Email: info@choicespine.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840996148108 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073669

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[00840996148108]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2017-03-01

Devices Manufactured by Choice Spine, LP

• 00840996176552 - BOOMERANG: 2026-01-23 BOOMERANG SELF DRILLING SCREWS 4.54X 13
• 00840996176569 - BOOMERANG: 2026-01-23 BOOMERANG,SCREW,SELF-DRILLING,4.5X15
• 00840996176576 - Boomerang: 2026-01-23 BOOMERANG SELF DRILLING SCREWS 4.54X 17
• 00840996176583 - BOOMERANG: 2026-01-23 BOOMERANG PLATE HOLDER
• 00840996176590 - BOOMERANG: 2026-01-23 BOOMERANG DRILL, 10MM
• 00840996176606 - Boomerang: 2026-01-23 Boomerang Combination Drill/Awl AO
• 00840996182119 - HARRIER-SA Lumbar Interbody System: 2024-03-05 HARRIER-SA,DRIVER,SPLIT-TIP
• 00840996150682 - Acapella One: 2024-03-04 ACAPELLA,TRIAL,LR,NS,12X14X5