Silverbolt/Mainframe 201-0280

GUDID 00840996174961

SILVERBOLT,ML,ROD,STRAIGHT,TI,5.5X80

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840996174961
• NIH Device Record Key: d9d73dfc-d6cc-4529-b62f-f2a09d15d3a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silverbolt/Mainframe
• Version Model Number: 201-0280
• Catalog Number: 201-0280
• 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

• Length: 80 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840996174961 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073245

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

[00840996174961]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-03
• Device Publish Date: 2018-11-02

On-Brand Devices [Silverbolt/Mainframe]

• 00840996175005: SILVERBOLT,ML,ROD,STRAIGHT,TI,5.5X100
• 00840996174992: SILVERBOLT,ML,ROD,STRAIGHT,TI,5.5X95
• 00840996174985: SILVERBOLT,ML,ROD,STRAIGHT,TI,5.5X90
• 00840996174978: SILVERBOLT,ML,ROD,STRAIGHT,TI,5.5X85
• 00840996174961: SILVERBOLT,ML,ROD,STRAIGHT,TI,5.5X80
• 00840996174954: SILVERBOLT,ML,ROD,STRAIGHT,TI,5.5X75
• 00840996174947: SILVERBOLT,ML,ROD,STRAIGHT,TI,5.5X70
• 00840996174930: SILVERBOLT,ML,ROD,STRAIGHT,TI,5.5X65
• 00840996170833: SILVERBOLT,ROD,PREBENT,TI,5.5X95
• 00840996170819: SILVERBOLT,SCREW,POLYAXIAL,5.5X80
• 00840996170802: SILVERBOLT,SCREW,POLYAXIAL,5.5X75
• 00840996170796: SILVERBOLT,SCREW,POLYAXIAL,5.5X70
• 00840996170789: SILVERBOLT,SCREW,POLYAXIAL,5.5X65
• 00840996170772: SILVERBOLT,SCREW,POLYAXIAL,5.5X60
• 00840996170765: SILVERBOLT,SCREW,POLYAXIAL,5.5X25
• 00840996170192: SILVERBOLT,SCREW,POLYAXIAL,6.5X80
• 00840996170185: SILVERBOLT,SCREW,POLYAXIAL,6.5X75
• 00840996170178: SILVERBOLT,SCREW,POLYAXIAL,6.5X70
• 00840996170161: SILVERBOLT,SCREW,POLYAXIAL,6.5X65
• 00840996170154: SILVERBOLT,SCREW,POLYAXIAL,6.5X30
• 00840996170147: SILVERBOLT,SCREW,POLYAXIAL,6.5X25
• 00840996157483: SILVERBOLT,CONNECTOR,42-58