Silverbolt 2 Pedicle Screw System

GUDID 00840996187381

SILVERBOLT,GUIDEWIRES,BLUNT,NONSTERILE

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840996187381
• NIH Device Record Key: 0759c30f-67a9-4796-ae98-92c339fe6d58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silverbolt 2 Pedicle Screw System
• Version Model Number: 200-9704
• 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	00840996187381 [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

[00840996187381]

Moist Heat or Steam Sterilization

[00840996187381]

Moist Heat or Steam Sterilization

[00840996187381]

Moist Heat or Steam Sterilization

[00840996187381]

Moist Heat or Steam Sterilization

[00840996187381]

Moist Heat or Steam Sterilization

[00840996187381]

Moist Heat or Steam Sterilization

[00840996187381]

Moist Heat or Steam Sterilization

[00840996187381]

Moist Heat or Steam Sterilization

[00840996187381]

Moist Heat or Steam Sterilization

[00840996187381]

Moist Heat or Steam Sterilization

[00840996187381]

Moist Heat or Steam Sterilization

[00840996187381]

Moist Heat or Steam Sterilization

[00840996187381]

Moist Heat or Steam Sterilization

[00840996187381]

Moist Heat or Steam Sterilization

[00840996187381]

Moist Heat or Steam Sterilization

[00840996187381]

Moist Heat or Steam Sterilization

[00840996187381]

Moist Heat or Steam Sterilization

[00840996187381]

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 2 Pedicle Screw System]

• 00840996160308: SBOLT,TORQ HANDLE SQ DRV, 60 INLB
• 00840996187381: SILVERBOLT,GUIDEWIRES,BLUNT,NONSTERILE
• 00840996187374: SILVERBOLT,GUIDEWIRES,NONSTERILE