TranS1 Anterior Cervical Plate System

GUDID 08806344363175

Variable Cervical Plate Screw, Self Drilling, Hex, Cylindrical, ∅ 3.5, 16mm

L&K BIOMED CO. ,LTD.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 08806344363175
• NIH Device Record Key: e8915381-2d0b-44db-a76b-ea6e6592ef30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TranS1 Anterior Cervical Plate System
• Version Model Number: 6504-3516
• 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	08806344363175 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143279

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[08806344363175]

Moist Heat or Steam Sterilization

[08806344363175]

Moist Heat or Steam Sterilization

[08806344363175]

Moist Heat or Steam Sterilization

[08806344363175]

Moist Heat or Steam Sterilization

[08806344363175]

Moist Heat or Steam Sterilization

[08806344363175]

Moist Heat or Steam Sterilization

[08806344363175]

Moist Heat or Steam Sterilization

[08806344363175]

Moist Heat or Steam Sterilization

[08806344363175]

Moist Heat or Steam Sterilization

[08806344363175]

Moist Heat or Steam Sterilization

[08806344363175]

Moist Heat or Steam Sterilization

[08806344363175]

Moist Heat or Steam Sterilization

[08806344363175]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2023-09-18
• Device Publish Date: 2018-03-05

On-Brand Devices [TranS1 Anterior Cervical Plate System]

• 08806344363182: Variable Cervical Plate Screw, Self Drilling, Hex, Cylindrical, ∅ 4.0, 14mm
• 08806344363175: Variable Cervical Plate Screw, Self Drilling, Hex, Cylindrical, ∅ 3.5, 16mm
• 08806344363083: Plate Screw (Self Drilling, Variable, Hex), 3.5x14mm
• 08806344363076: Cervical Plate Screw, Self-drilling, Cylinderical, Variable, Dia 3.5mm, Working length 12.0 mm