HAWKEYE™ Vertebral Body Replacement (VBR)

GUDID 00840996129237

VBR,CALIPER

Choice Spine, LP

Polymeric spinal interbody fusion cage

• Primary Device ID: 00840996129237
• NIH Device Record Key: ace170fb-9835-4b7e-99de-d1181c82158e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HAWKEYE™ Vertebral Body Replacement (VBR)
• Version Model Number: D070-0010
• 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	00840996129237 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120570

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[00840996129237]

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: 2016-03-18

On-Brand Devices [HAWKEYE™ Vertebral Body Replacement (VBR)]

• 00840996129237: VBR,CALIPER
• 00840996129220: VBR,TRIAL,DUAL,CASPAR STOPS
• 00840996129213: VBR,RAMP
• 00840996123006: VBR,SPACER,14X16X18,0 DEG
• 00840996102322: VBR,SPACER,14X16X50,6 DEG
• 00840996102315: VBR,SPACER,14X16X49,6 DEG
• 00840996102308: VBR,SPACER,14X16X48,6 DEG
• 00840996102292: VBR,SPACER,14X16X47,6 DEG
• 00840996102285: VBR,SPACER,14X16X46,6 DEG
• 00840996102278: VBR,SPACER,14X16X45,6 DEG
• 00840996102261: VBR,SPACER,14X16X44,6 DEG
• 00840996102254: VBR,SPACER,14X16X43,6 DEG
• 00840996102247: VBR,SPACER,14X16X42,6 DEG
• 00840996102230: VBR,SPACER,14X16X41,6 DEG
• 00840996102223: VBR,SPACER,14X16X40,6 DEG
• 00840996102216: VBR,SPACER,14X16X39,6 DEG
• 00840996102209: VBR,SPACER,14X16X38,6 DEG
• 00840996102193: VBR,SPACER,14X16X37,6 DEG
• 00840996102186: VBR,SPACER,14X16X36,6 DEG
• 00840996102179: VBR,SPACER,14X16X35,6 DEG
• 00840996102162: VBR,SPACER,14X16X34,6 DEG
• 00840996102155: VBR,SPACER,14X16X33,6 DEG
• 00840996102148: VBR,SPACER,14X16X32,6 DEG
• 00840996102131: VBR,SPACER,14X16X31,6 DEG
• 00840996102124: VBR,SPACER,14X16X30,6 DEG
• 00840996102117: VBR,SPACER,14X16X29,6 DEG
• 00840996102100: VBR,SPACER,14X16X28,6 DEG
• 00840996102094: VBR,SPACER,14X16X27,6 DEG
• 00840996102087: VBR,SPACER,14X16X26,6 DEG
• 00840996102070: VBR,SPACER,14X16X25,6 DEG
• 00840996102063: VBR,SPACER,14X16X24,6 DEG
• 00840996102056: VBR,SPACER,14X16X23,6 DEG
• 00840996102049: VBR,SPACER,14X16X22,6 DEG
• 00840996102032: VBR,SPACER,14X16X21,6 DEG
• 00840996102025: VBR,SPACER,14X16X20,6 DEG
• 00840996102018: VBR,SPACER,14X16X19,6 DEG
• 00840996102001: VBR,SPACER,14X16X18,6 DEG
• 00840996101998: VBR,SPACER,14X16X17,6 DEG
• 00840996101981: VBR,SPACER,14X16X16,6 DEG
• 00840996101974: VBR,SPACER,14X16X15,6 DEG
• 00840996101967: VBR,SPACER,14X16X14,6 DEG
• 00840996101950: VBR,SPACER,14X16X13,6 DEG
• 00840996101943: VBR,SPACER,14X16X12,6 DEG
• 00840996101936: VBR,SPACER,14X16X11,6 DEG
• 00840996101929: VBR,SPACER,14X16X10,6 DEG
• 00840996101912: VBR,SPACER,14X16X50,0 DEG
• 00840996101905: VBR,SPACER,14X16X49,0 DEG
• 00840996101899: VBR,SPACER,14X16X48,0 DEG
• 00840996101882: VBR,SPACER,14X16X47,0 DEG
• 00840996101875: VBR,SPACER,14X16X46,0 DEG