LnK/CastleLoc-S Posterior Cervical Fixation System

GUDID 08800108646078

Cervical Poly Axial Screw – screw neck Ø 2.4 4.5x46mm

L&K BIOMED CO. ,LTD.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 08800108646078
• NIH Device Record Key: b01e3680-5919-4044-8b81-16b244e8a9d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LnK/CastleLoc-S Posterior Cervical Fixation System
• Version Model Number: 6111-4546
• 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	08800108646078 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200793

FDA Product Code

• NKG: Posterior Cervical Screw System

Sterilization

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

[08800108646078]

Moist Heat or Steam Sterilization

[08800108646078]

Moist Heat or Steam Sterilization

[08800108646078]

Moist Heat or Steam Sterilization

[08800108646078]

Moist Heat or Steam Sterilization

[08800108646078]

Moist Heat or Steam Sterilization

[08800108646078]

Moist Heat or Steam Sterilization

[08800108646078]

Moist Heat or Steam Sterilization

[08800108646078]

Moist Heat or Steam Sterilization

[08800108646078]

Moist Heat or Steam Sterilization

[08800108646078]

Moist Heat or Steam Sterilization

[08800108646078]

Moist Heat or Steam Sterilization

[08800108646078]

Moist Heat or Steam Sterilization

[08800108646078]

Moist Heat or Steam Sterilization

[08800108646078]

Moist Heat or Steam Sterilization

[08800108646078]

Moist Heat or Steam Sterilization

[08800108646078]

Moist Heat or Steam Sterilization

[08800108646078]

Moist Heat or Steam Sterilization

[08800108646078]

Moist Heat or Steam Sterilization

[08800108646078]

Moist Heat or Steam Sterilization

[08800108646078]

Moist Heat or Steam Sterilization

[08800108646078]

Moist Heat or Steam Sterilization

[08800108646078]

Moist Heat or Steam Sterilization

[08800108646078]

Moist Heat or Steam Sterilization

[08800108646078]

Moist Heat or Steam Sterilization

[08800108646078]

Moist Heat or Steam Sterilization

[08800108646078]

Moist Heat or Steam Sterilization

[08800108646078]

Moist Heat or Steam Sterilization

[08800108646078]

Moist Heat or Steam Sterilization

[08800108646078]

Moist Heat or Steam Sterilization

[08800108646078]

Moist Heat or Steam Sterilization

[08800108646078]

Moist Heat or Steam Sterilization

[08800108646078]

Moist Heat or Steam Sterilization

[08800108646078]

Moist Heat or Steam Sterilization

[08800108646078]

Moist Heat or Steam Sterilization

[08800108646078]

Moist Heat or Steam Sterilization

[08800108646078]

Moist Heat or Steam Sterilization

[08800108646078]

Moist Heat or Steam Sterilization

[08800108646078]

Moist Heat or Steam Sterilization

[08800108646078]

Moist Heat or Steam Sterilization

[08800108646078]

Moist Heat or Steam Sterilization

[08800108646078]

Moist Heat or Steam Sterilization

[08800108646078]

Moist Heat or Steam Sterilization

[08800108646078]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-12
• Device Publish Date: 2021-05-04

On-Brand Devices [LnK/CastleLoc-S Posterior Cervical Fixation System]

• 08806344322424: Left Side Rod to Rod Connector
• 08806344322417: Left Side Rod to Rod Connector
• 08806344322400: Left Side Rod to Rod Connector
• 08806344322370: Left Side Rod to Rod Connector
• 08806344322363: Left Side Rod to Rod Connector
• 08806344322356: Left Side Rod to Rod Connector
• 08806344322349: Left Side Rod to Rod Connector
• 08806344322332: Left Side Rod to Rod Connector
• 08806344322325: Left Side Rod to Rod Connector
• 08806344322318: Left Side Rod to Rod Connector
• 08806344322301: Left Side Rod to Rod Connector
• 08806344322295: Left Side Rod to Rod Connector
• 08806344322288: Left Side Rod to Rod Connector
• 08806344322271: Left Side Rod to Rod Connector
• 08806344322264: Left Side Rod to Rod Connector
• 08806344322486: Left Side Rod to Rod Connector
• 08806344322479: Left Side Rod to Rod Connector
• 08806344322462: Left Side Rod to Rod Connector
• 08806344322448: Left Side Rod to Rod Connector
• 08806344322257: Left Side Rod to Rod Connector
• 08806344322455: Left Side Rod to Rod Connector
• 08806344322431: Left Side Rod to Rod Connector
• 08806344322394: Left Side Rod to Rod Connector
• 08806344322387: Left Side Rod to Rod Connector
• 08806344322134: Right Side Rod to Rod Connector
• 08800108646030: Cervical Poly Axial Screw – screw neck Ø 2.4 4.5x38mm
• 08800108646023: Cervical Poly Axial Screw – screw neck Ø 2.4 4.5x36mm
• 08800108646016: Cervical Poly Axial Screw – screw neck Ø 2.4 4.5x34mm
• 08800108646009: Cervical Poly Axial Screw – screw neck Ø 2.4 4.5x32mm
• 08800108645996: Cervical Poly Axial Screw – screw neck Ø 2.4 4.5x30mm
• 08800108645989: Cervical Poly Axial Screw – screw neck Ø 2.4 4.5x28mm
• 08800108645972: Cervical Poly Axial Screw – screw neck Ø 2.4 4.5x26mm
• 08800108645965: Cervical Poly Axial Screw – screw neck Ø 2.4 4.5x24mm
• 08800108645958: Cervical Poly Axial Screw – screw neck Ø 2.4 4.5x22mm
• 08800108645941: Cervical Poly Axial Screw – screw neck Ø 2.4 4.5x20mm
• 08800108645934: Cervical Poly Axial Screw – screw neck Ø 2.4 4.5x18mm
• 08800108645927: Cervical Poly Axial Screw – screw neck Ø 2.4 4.5x16mm
• 08800108645910: Cervical Poly Axial Screw – screw neck Ø 2.4 4.5x14mm
• 08800108645903: Cervical Poly Axial Screw – screw neck Ø 2.4 4.5x12mm
• 08800108645897: Cervical Poly Axial Screw – screw neck Ø 2.4 4.5x10mm
• 08800108646337: Cervical Poly Axial Screw – screw neck Ø 2.4 5.5x14mm
• 08800108646320: Cervical Poly Axial Screw – screw neck Ø 2.4 5.5x12mm
• 08800108646313: Cervical Poly Axial Screw – screw neck Ø 2.4 5.5x10mm
• 08800108646306: Cervical Poly Axial Screw – screw neck Ø 2.4 5x50mm
• 08800108646290: Cervical Poly Axial Screw – screw neck Ø 2.4 5x48mm
• 08800108646283: Cervical Poly Axial Screw – screw neck Ø 2.4 5x46mm
• 08800108646276: Cervical Poly Axial Screw – screw neck Ø 2.4 5x44mm
• 08800108646269: Cervical Poly Axial Screw – screw neck Ø 2.4 5x42mm
• 08800108646252: Cervical Poly Axial Screw – screw neck Ø 2.4 5x40mm
• 08800108646245: Cervical Poly Axial Screw – screw neck Ø 2.4 5x38mm