Silverbolt/Mainframe Instruments

GUDID 00840996187398

SILVERBOLT,TISSUE SPLIT BLD,(2)

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840996187398
• NIH Device Record Key: 0078b906-bd53-40a7-814e-f4dd659af029
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silverbolt/Mainframe Instruments
• Version Model Number: 200-9703
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840996187398 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062670

FDA Product Code

• LXH: Orthopedic manual surgical instrument

Sterilization

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

[00840996187398]

Moist Heat or Steam Sterilization

[00840996187398]

Moist Heat or Steam Sterilization

[00840996187398]

Moist Heat or Steam Sterilization

[00840996187398]

Moist Heat or Steam Sterilization

[00840996187398]

Moist Heat or Steam Sterilization

[00840996187398]

Moist Heat or Steam Sterilization

[00840996187398]

Moist Heat or Steam Sterilization

[00840996187398]

Moist Heat or Steam Sterilization

[00840996187398]

Moist Heat or Steam Sterilization

[00840996187398]

Moist Heat or Steam Sterilization

[00840996187398]

Moist Heat or Steam Sterilization

[00840996187398]

Moist Heat or Steam Sterilization

[00840996187398]

Moist Heat or Steam Sterilization

[00840996187398]

Moist Heat or Steam Sterilization

[00840996187398]

Moist Heat or Steam Sterilization

[00840996187398]

Moist Heat or Steam Sterilization

[00840996187398]

Moist Heat or Steam Sterilization

[00840996187398]

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 [Silverbolt/Mainframe Instruments]

• 00840996169233: S'BOLT,DRIVER,POLY,SOLID,MAINFRAME
• 00840996169226: S'BOLT,CANN,DR,POLY,MAINFRAME
• 00840996163576: SILVERBOLT,TAP, W REAMER TIP, 7.0
• 00840996163569: SILVERBOLT,TAP, W REAMER TIP, 6.0
• 00840996157469: SILVERBOLT,DRIVER, X-15
• 00840996156615: SILVERBOLT,ROD REDUCER
• 00840996187398: SILVERBOLT,TISSUE SPLIT BLD,(2)
• 00840996181297: SILVERBOLT, TAP, W REAMER, 5.5