L118-5555

GUDID 08800033120155

GBS Commonwealth Co.,Ltd.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 08800033120155
• NIH Device Record Key: e6a45e93-4dd9-4723-9b88-72a68c7756ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: L118-5555
• Version Model Number: L118-5555
• Company DUNS: 694609156
• Company Name: GBS Commonwealth Co.,Ltd.
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800033120155 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173645

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[08800033120155]

Moist Heat or Steam Sterilization

[08800033120155]

Moist Heat or Steam Sterilization

[08800033120155]

Moist Heat or Steam Sterilization

[08800033120155]

Moist Heat or Steam Sterilization

[08800033120155]

Moist Heat or Steam Sterilization

[08800033120155]

Moist Heat or Steam Sterilization

[08800033120155]

Moist Heat or Steam Sterilization

[08800033120155]

Moist Heat or Steam Sterilization

[08800033120155]

Moist Heat or Steam Sterilization

[08800033120155]

Moist Heat or Steam Sterilization

[08800033120155]

Moist Heat or Steam Sterilization

[08800033120155]

Moist Heat or Steam Sterilization

[08800033120155]

Moist Heat or Steam Sterilization

[08800033120155]

Moist Heat or Steam Sterilization

[08800033120155]

Moist Heat or Steam Sterilization

[08800033120155]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-08
• Device Publish Date: 2019-03-30

Devices Manufactured by GBS Commonwealth Co.,Ltd.

• 08800033811107 - The JASPER Spinal Fixation System: 2025-02-07
• 08800033811114 - The JASPER Spinal Fixation System: 2025-02-07
• 08800033811121 - The JASPER Spinal Fixation System: 2025-02-07
• 08800033811138 - The JASPER Spinal Fixation System: 2025-02-07
• 08800033811145 - The JASPER Spinal Fixation System: 2025-02-07
• 08800033811152 - The JASPER Spinal Fixation System: 2025-02-07
• 08800033811169 - The JASPER Spinal Fixation System: 2025-02-07
• 08800033811176 - The JASPER Spinal Fixation System: 2025-02-07