Harrier-SA LUMBAR INTERBODY SYSTEM

GUDID 00840996186346

HARRIER-SA,DISTRACTOR,24X10X12,10 DEG

Choice Spine, LP

Intervertebral-body internal spinal fixation system

• Primary Device ID: 00840996186346
• NIH Device Record Key: 13b19f0a-d0f6-4756-86ee-c2b9895bbc49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Harrier-SA LUMBAR INTERBODY SYSTEM
• Version Model Number: Y070-24101012B
• Company DUNS: 078293017
• Company Name: Choice Spine, LP
• Device Count: 1
• DM Exempt: true
• 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	00840996186346 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180519

FDA Product Code

• LXH: Orthopedic manual surgical instrument

Sterilization

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

[00840996186346]

Moist Heat or Steam Sterilization

[00840996186346]

Moist Heat or Steam Sterilization

[00840996186346]

Moist Heat or Steam Sterilization

[00840996186346]

Moist Heat or Steam Sterilization

[00840996186346]

Moist Heat or Steam Sterilization

[00840996186346]

Moist Heat or Steam Sterilization

[00840996186346]

Moist Heat or Steam Sterilization

[00840996186346]

Moist Heat or Steam Sterilization

[00840996186346]

Moist Heat or Steam Sterilization

[00840996186346]

Moist Heat or Steam Sterilization

[00840996186346]

Moist Heat or Steam Sterilization

[00840996186346]

Moist Heat or Steam Sterilization

[00840996186346]

Moist Heat or Steam Sterilization

[00840996186346]

Moist Heat or Steam Sterilization

[00840996186346]

Moist Heat or Steam Sterilization

[00840996186346]

Moist Heat or Steam Sterilization

[00840996186346]

Moist Heat or Steam Sterilization

[00840996186346]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-14
• Device Publish Date: 2023-07-06

On-Brand Devices [Harrier-SA LUMBAR INTERBODY SYSTEM]

• 00840996177399: HARRIER-SA,TRIAL,STARTER
• 00840996177078: HARRIER-SA,SCREW,5.0X60MM
• 00840996177061: HARRIER-SA,SCREW,5.0X55MM
• 00840996177054: HARRIER-SA,SCREW,5.0X50MM
• 00840996177047: HARRIER-SA,SCREW,5.0X45MM
• 00840996177030: HARRIER-SA,SCREW,5.5X60
• 00840996177023: HARRIER-SA,SCREW,5.5X55
• 00840996177016: HARRIER-SA,SCREW,5.5X50
• 00840996177009: HARRIER-SA,SCREW,5.5X45
• 00840996174718: HARRIER-SA,INSERTER
• 00840996174572: HARRIER-SA,GRAFT BLOCK
• 00840996174565: HARRIER-SA,MALLET
• 00840996174473: HARRIER-SA,COVERPLATE,ZERO,ASSY,23
• 00840996174466: HARRIER-SA,COVERPLATE,ZERO,ASSY,21
• 00840996174459: HARRIER-SA,COVERPLATE,ZERO,ASSY,19
• 00840996174442: HARRIER-SA,COVERPLATE,ZERO,ASSY,17
• 00840996174435: HARRIER-SA,COVERPLATE,ZERO,ASSY,15
• 00840996174428: HARRIER-SA,COVERPLATE,ZERO,ASSY,13
• 00840996174411: HARRIER-SA,COVERPLATE,ZERO,ASSY,12
• 00840996174398: HARRIER-SA,AWL,VARIABLE,ANGLE
• 00840996174381: HARRIER-SA,DRIVER,VARAIBLE,ANGLE
• 00840996174374: HARRIER-SA,AWL GUIDE
• 00840996173629: HARRIER-SA,STRAIGHT DRIVER
• 00840996173612: HARRIER-SA,STRAIGHT AWL
• 00840996173605: HARRIER-SA,DRIVER,FIXED,ANGLE
• 00840996173599: HARRIER-SA,ANGLED AWL
• 00840996173575: HARRIER-SA,RETRACTABLE AWL
• 00840996173568: HARRIER-SA,SPREADER
• 00840996173551: HARRIER-SA,TRIAL,28x36x23,30 DEG
• 00840996173544: HARRIER-SA,TRIAL,28x36x21,30 DEG
• 00840996173537: HARRIER-SA,TRIAL,28x36x19,30 DEG
• 00840996173520: HARRIER-SA,TRIAL,28x36x21,25 DEG
• 00840996173513: HARRIER-SA,TRIAL,28x36x19,25 DEG
• 00840996173506: HARRIER-SA,TRIAL,28x36x17,25 DEG
• 00840996173490: HARRIER-SA,TRIAL,28x36x15,25 DEG
• 00840996173483: HARRIER-SA,TRIAL,28x36x19,20 DEG
• 00840996173476: HARRIER-SA,TRIAL,28x36x17,20 DEG
• 00840996173469: HARRIER-SA,TRIAL,28x36x15,20 DEG
• 00840996173452: HARRIER-SA,TRIAL,28x36x13,20 DEG
• 00840996173445: HARRIER-SA,TRIAL,28x36x19,15 DEG
• 00840996173438: HARRIER-SA,TRIAL,28x36x17,15 DEG
• 00840996173421: HARRIER-SA,TRIAL,28x36x15,15 DEG
• 00840996173414: HARRIER-SA,TRIAL,28x36x13,15 DEG
• 00840996173407: HARRIER-SA,TRIAL,28x36x12,15 DEG
• 00840996173391: HARRIER-SA,TRIAL,28x36x19,10 DEG
• 00840996173384: HARRIER-SA,TRIAL,28x36x17,10 DEG
• 00840996173377: HARRIER-SA,TRIAL,28x36x15,10 DEG
• 00840996173360: HARRIER-SA,TRIAL,28x36x13,10 DEG
• 00840996173353: HARRIER-SA,TRIAL,28x36x12,10 DEG
• 00840996173346: HARRIER-SA,TRIAL,26x32x19,15 DEG