Harrier SA

GUDID 00840996184007

HARRIER-SA,SCREW,5.0x35

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840996184007
• NIH Device Record Key: cc1b5bd7-00ef-44c0-b33c-f21dfdcdf363
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Harrier SA
• Version Model Number: YT35-5035
• 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	00840996184007 [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

[00840996184007]

Moist Heat or Steam Sterilization

[00840996184007]

Moist Heat or Steam Sterilization

[00840996184007]

Moist Heat or Steam Sterilization

[00840996184007]

Moist Heat or Steam Sterilization

[00840996184007]

Moist Heat or Steam Sterilization

[00840996184007]

Moist Heat or Steam Sterilization

[00840996184007]

Moist Heat or Steam Sterilization

[00840996184007]

Moist Heat or Steam Sterilization

[00840996184007]

Moist Heat or Steam Sterilization

[00840996184007]

Moist Heat or Steam Sterilization

[00840996184007]

Moist Heat or Steam Sterilization

[00840996184007]

Moist Heat or Steam Sterilization

[00840996184007]

Moist Heat or Steam Sterilization

[00840996184007]

Moist Heat or Steam Sterilization

[00840996184007]

Moist Heat or Steam Sterilization

[00840996184007]

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 [Harrier SA]

• 00840996177245: Harrier SA 26x32x8, 10 Deg
• 00840996177238: 28x36x10,10deg Trial
• 00840996177221: 28x36x8,10deg Trial
• 00840996184052: HARRIER-SA,SCREW,5.5X40
• 00840996184045: HARRIER-SA,SCREW,5.5X35
• 00840996184038: HARRIER-SA,SCREW,5.5X30
• 00840996184021: HARRIER-SA,SCREW,5.5X25
• 00840996184014: HARRIER-SA,SCREW,5.5X20
• 00840996184007: HARRIER-SA,SCREW,5.0x35
• 00840996183994: HARRIER-SA,SCREW,5.0x40
• 00840996183987: HARRIER-SA,SCREW,5.0x30
• 00840996183970: HARRIER-SA,SCREW,5.0x25
• 00840996183963: HARRIER-SA,SCREW,5.0x20
• 00840996192965: HARRIER-SA,TRIAL,START WEDGE IMPACT 6H
• 00840996192958: HARRIER-SA,TRIAL,START WEDGE IMPACT 8H