LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fi 1250-55500

GUDID 08800061396331

S Rod (Round Type)

L&K BIOMED CO. ,LTD.

Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 08800061396331
• NIH Device Record Key: f300de19-fd1b-44eb-98a9-9a92e0e2dbfe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fi
• Version Model Number: 1250-55500
• Catalog Number: 1250-55500
• Company DUNS: 631159324
• Company Name: L&K BIOMED CO. ,LTD.
• Device Count: 1
• DM Exempt: true
• 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	08800061396331 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232311

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[08800061396331]

Moist Heat or Steam Sterilization

[08800061396331]

Moist Heat or Steam Sterilization

[08800061396331]

Moist Heat or Steam Sterilization

[08800061396331]

Moist Heat or Steam Sterilization

[08800061396331]

Moist Heat or Steam Sterilization

[08800061396331]

Moist Heat or Steam Sterilization

[08800061396331]

Moist Heat or Steam Sterilization

[08800061396331]

Moist Heat or Steam Sterilization

[08800061396331]

Moist Heat or Steam Sterilization

[08800061396331]

Moist Heat or Steam Sterilization

[08800061396331]

Moist Heat or Steam Sterilization

[08800061396331]

Moist Heat or Steam Sterilization

[08800061396331]

Moist Heat or Steam Sterilization

[08800061396331]

Moist Heat or Steam Sterilization

[08800061396331]

Moist Heat or Steam Sterilization

[08800061396331]

Moist Heat or Steam Sterilization

[08800061396331]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-15
• Device Publish Date: 2023-11-07

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

• 08800061396805: S Rod (HEX Type)
• 08800061396713: S Rod (HEX Type)
• 08800061396621: S Rod (HEX Type)
• 08800061396331: S Rod (Round Type)
• 08800061396157: S Rod (Round Type)
• 08800061397413: S Rod (HEX Type)
• 08800061397147: S Rod (HEX Type)