LnK/OpenLoc-L Spinal Fixation System

GUDID 08806344397132

Crosslink 40-53mm

L&K BIOMED CO. ,LTD.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 08806344397132
• NIH Device Record Key: 0377ffca-020b-4262-ab8e-85cb93fae4d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LnK/OpenLoc-L Spinal Fixation System
• Version Model Number: 1043-0048
• 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	08806344397132 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183168

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[08806344397132]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-11
• Device Publish Date: 2019-04-03

On-Brand Devices [LnK/OpenLoc-L Spinal Fixation System]

• 08806344397149: Crosslink 50-70mm
• 08806344397132: Crosslink 40-53mm
• 08806344397125: Crosslink 34-42mm
• 08806344397118: Crosslink 30-34mm
• 08806344348288: Mono Axial Screw Ø7.0, 70mm
• 08806344348295: Mono Axial Screw Ø7.0, 75mm
• 08800108623277: Crosslink46-54mm
• 08800108623260: Crosslink40-48mm
• 08800108623253: Crosslink34-42mm
• 08800108623246: Crosslink30-34mm