LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System

GUDID 08800061396980

S Rod (HEX Type)

L&K BIOMED CO. ,LTD.

Bone-screw internal spinal fixation system rod

• Primary Device ID: 08800061396980
• NIH Device Record Key: 10350ecc-cc77-4417-aecd-78bf0470e7c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System
• Version Model Number: 1480-55250
• 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	08800061396980 [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

[08800061396980]

Moist Heat or Steam Sterilization

[08800061396980]

Moist Heat or Steam Sterilization

[08800061396980]

Moist Heat or Steam Sterilization

[08800061396980]

Moist Heat or Steam Sterilization

[08800061396980]

Moist Heat or Steam Sterilization

[08800061396980]

Moist Heat or Steam Sterilization

[08800061396980]

Moist Heat or Steam Sterilization

[08800061396980]

Moist Heat or Steam Sterilization

[08800061396980]

Moist Heat or Steam Sterilization

[08800061396980]

Moist Heat or Steam Sterilization

[08800061396980]

Moist Heat or Steam Sterilization

[08800061396980]

Moist Heat or Steam Sterilization

[08800061396980]

Moist Heat or Steam Sterilization

[08800061396980]

Moist Heat or Steam Sterilization

[08800061396980]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-10
• Device Publish Date: 2025-04-02

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

• 08800108699982: W Type Domino Connector
• 08800108699975: W Type Domino Connector
• 08800108699968: W Type Domino Connector
• 08800061397468: S Rod (HEX Type)
• 08800061397451: S Rod (HEX Type)
• 08800061397444: S Rod (HEX Type)
• 08800061397437: S Rod (HEX Type)
• 08800061397420: S Rod (HEX Type)
• 08800061397376: S Rod (HEX Type)
• 08800061397369: S Rod (HEX Type)
• 08800061397352: S Rod (HEX Type)
• 08800061397345: S Rod (HEX Type)
• 08800061397338: S Rod (HEX Type)
• 08800061397321: S Rod (HEX Type)
• 08800061397284: S Rod (HEX Type)
• 08800061397277: S Rod (HEX Type)
• 08800061397260: S Rod (HEX Type)
• 08800061397253: S Rod (HEX Type)
• 08800061397246: S Rod (HEX Type)
• 08800061397239: S Rod (HEX Type)
• 08800061397192: S Rod (HEX Type)
• 08800061397185: S Rod (HEX Type)
• 08800061397178: S Rod (HEX Type)
• 08800061397154: S Rod (HEX Type)
• 08800061397109: S Rod (HEX Type)
• 08800061397093: S Rod (HEX Type)
• 08800061397086: S Rod (HEX Type)
• 08800061397079: S Rod (HEX Type)
• 08800061397062: S Rod (HEX Type)
• 08800061397024: S Rod (HEX Type)
• 08800061397017: S Rod (HEX Type)
• 08800061397000: S Rod (HEX Type)
• 08800061396997: S Rod (HEX Type)
• 08800061396980: S Rod (HEX Type)
• 08800061396973: S Rod (HEX Type)
• 08800061396966: S Rod (HEX Type)
• 08800061396928: S Rod (HEX Type)
• 08800061396911: S Rod (HEX Type)
• 08800061396904: S Rod (HEX Type)
• 08800061396898: S Rod (HEX Type)
• 08800061396881: S Rod (HEX Type)
• 08800061396874: S Rod (HEX Type)
• 08800061396836: S Rod (HEX Type)
• 08800061396829: S Rod (HEX Type)
• 08800061396812: S Rod (HEX Type)
• 08800061396799: S Rod (HEX Type)
• 08800061396782: S Rod (HEX Type)
• 08800061396744: S Rod (HEX Type)
• 08800061396737: S Rod (HEX Type)
• 08800061396720: S Rod (HEX Type)