TIGERSHARK C

GUDID 00840996192941

TIGERSHARK C,SHAFT INSERTER

Choice Spine, LP

Polymeric spinal interbody fusion cage

• Primary Device ID: 00840996192941
• NIH Device Record Key: ce7796aa-15d5-4d6b-8f6d-521cac47452c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TIGERSHARK C
• Version Model Number: D070-0016
• 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	00840996192941 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183397

FDA Product Code

• LXH: Orthopedic manual surgical instrument

Sterilization

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

[00840996192941]

Moist Heat or Steam Sterilization

[00840996192941]

Moist Heat or Steam Sterilization

[00840996192941]

Moist Heat or Steam Sterilization

[00840996192941]

Moist Heat or Steam Sterilization

[00840996192941]

Moist Heat or Steam Sterilization

[00840996192941]

Moist Heat or Steam Sterilization

[00840996192941]

Moist Heat or Steam Sterilization

[00840996192941]

Moist Heat or Steam Sterilization

[00840996192941]

Moist Heat or Steam Sterilization

[00840996192941]

Moist Heat or Steam Sterilization

[00840996192941]

Moist Heat or Steam Sterilization

[00840996192941]

Moist Heat or Steam Sterilization

[00840996192941]

Moist Heat or Steam Sterilization

[00840996192941]

Moist Heat or Steam Sterilization

[00840996192941]

Moist Heat or Steam Sterilization

[00840996192941]

Moist Heat or Steam Sterilization

[00840996192941]

Moist Heat or Steam Sterilization

[00840996192941]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-28
• Device Publish Date: 2023-04-20

Devices Manufactured by Choice Spine, LP

• 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
• 00840996150699 - Acapella One: 2024-03-04 ACAPELLA,TRIAL,LR,NS,12X14X6
• 00840996150705 - Acapella One: 2024-03-04 ACAPELLA,TRIAL,LR,NS,12X14X7
• 00840996150712 - Acapella One: 2024-03-04 ACAPELLA,TRIAL,LR,NS,12X14X8
• 00840996150729 - Acapella One: 2024-03-04 ACAPELLA,TRIAL,LR,NS,12X14X9
• 00840996150736 - Acapella One: 2024-03-04 ACAPELLA,TRIAL,LR,NS,12X14X10
• 00840996150743 - Acapella One: 2024-03-04 ACAPELLA,TRIAL,LR,NS,12X14X11