Dynabolt

GUDID 00840996170932

SILVERBOLT,ROD,DYN,STRAIGHT,TI,5.5X90

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840996170932
• NIH Device Record Key: 318eff31-b9cd-4b85-872e-3bb2c9a20b35
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dynabolt
• Version Model Number: 300-4190
• 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

Device Dimensions

• Outer Diameter: 5.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840996170932 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073143

FDA Product Code

• MNH: Orthosis, spondylolisthesis spinal fixation

Sterilization

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

[00840996170932]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-17

On-Brand Devices [Dynabolt]

• 00840996170970: SILVERBOLT,ROD,DYN,STRAIGHT,TI,5.5X200
• 00840996170963: SILVERBOLT,ROD,DYN,STRAIGHT,TI,5.5X120
• 00840996170956: SILVERBOLT,ROD,DYN,STRAIGHT,TI,5.5X100
• 00840996170949: SILVERBOLT,ROD,DYN,STRAIGHT,TI,5.5X95
• 00840996170932: SILVERBOLT,ROD,DYN,STRAIGHT,TI,5.5X90
• 00840996170925: SILVERBOLT,ROD,DYN,STRAIGHT,TI,5.5X85
• 00840996170918: SILVERBOLT,ROD,DYN,STRAIGHT,TI,5.5X80
• 00840996170901: SILVERBOLT,ROD,DYN,STRAIGHT,TI,5.5X75
• 00840996170895: SILVERBOLT,ROD,DYN,STRAIGHT,TI,5.5X70
• 00840996170888: SILVERBOLT,ROD,DYN,STRAIGHT,TI,5.5X65
• 00840996170871: SILVERBOLT,ROD,DYN,PREBENT,TI,5.5X100
• 00840996170864: SILVERBOLT,ROD,DYN,PREBENT,TI,5.5X95
• 00840996170857: SILVERBOLT,ROD,DYN,PREBENT,TI,5.5X85
• 00840996170840: SILVERBOLT,ROD,DYN,PREBENT,TI,5.5X75