TranS1 Cervical Interbody Fusion Cage System 5108-1214

GUDID 08806344362437

Cervical Cage 12, 14, 08mm 0°

L&K BIOMED CO. ,LTD.

Polymeric spinal interbody fusion cage

• Primary Device ID: 08806344362437
• NIH Device Record Key: f7a1beee-627d-4d88-8515-9e2fe35f12ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TranS1 Cervical Interbody Fusion Cage System
• Version Model Number: 5108-1214
• Catalog Number: 5108-1214
• Company DUNS: 631159324
• Company Name: L&K BIOMED 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	08806344362437 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151677

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[08806344362437]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2017-09-13

On-Brand Devices [TranS1 Cervical Interbody Fusion Cage System]

• 08806344363168: Cervical Cage, 0°, 14X17X9mm
• 08806344363151: Cervical Cage, 0°, 14X17X8mm
• 08806344363144: Cervical Cage, 0°, 14X17X7mm
• 08806344363052: Cervical Cage A-P Length 14mm, M-L Width 17mm, Height 6mm
• 08806344363045: Cervical Cage A-P Length 12mm, M-L Width 14mm, Height 6mm
• 08806344363038: Cervical Cage A-P Length 14mm, M-L Width 17mm, Height 5mm
• 08806344363021: Cervical Cage A-P Length 12mm, M-L Width 14mm, Height 5mm
• 08806344362444: Cervical Cage 12, 14, 07mm 0°
• 08806344362437: Cervical Cage 12, 14, 08mm 0°