CastleLoc Spinal Fixation System/LnK Basic Spinal Fixation System 1511-8045

GUDID 08806344324046

Mono Axial Screw(Non-Self Tapping) Ø8.0, 45mm

L&K BIOMED CO. ,LTD.

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 08806344324046
• NIH Device Record Key: 96beed28-693f-4515-8450-e3bb7d9df12c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CastleLoc Spinal Fixation System/LnK Basic Spinal Fixation System
• Version Model Number: 1511-8045
• Catalog Number: 1511-8045
• 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	08806344324046 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162801

FDA Product Code

• MNH: Orthosis, Spondylolisthesis Spinal Fixation

Sterilization

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

[08806344324046]

Moist Heat or Steam Sterilization

[08806344324046]

Moist Heat or Steam Sterilization

[08806344324046]

Moist Heat or Steam Sterilization

[08806344324046]

Moist Heat or Steam Sterilization

[08806344324046]

Moist Heat or Steam Sterilization

[08806344324046]

Moist Heat or Steam Sterilization

[08806344324046]

Moist Heat or Steam Sterilization

[08806344324046]

Moist Heat or Steam Sterilization

[08806344324046]

Moist Heat or Steam Sterilization

[08806344324046]

Moist Heat or Steam Sterilization

[08806344324046]

Moist Heat or Steam Sterilization

[08806344324046]

Moist Heat or Steam Sterilization

[08806344324046]

Moist Heat or Steam Sterilization

[08806344324046]

Moist Heat or Steam Sterilization

[08806344324046]

Moist Heat or Steam Sterilization

[08806344324046]

Moist Heat or Steam Sterilization

[08806344324046]

Moist Heat or Steam Sterilization

[08806344324046]

Moist Heat or Steam Sterilization

[08806344324046]

Moist Heat or Steam Sterilization

[08806344324046]

Moist Heat or Steam Sterilization

[08806344324046]

Moist Heat or Steam Sterilization

[08806344324046]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-06-05
• Device Publish Date: 2016-11-21

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