"LnK Posterior Cervical Fixation System/ CastleLoc-S Posterior Cervical Fixation

GUDID 08809986479242

Partially Semi Poly Screw 5.0X46mm

L&K BIOMED CO. ,LTD.

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 08809986479242
• NIH Device Record Key: 3d449981-943e-44a2-bc69-25ea5b4d1a88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: "LnK Posterior Cervical Fixation System/ CastleLoc-S Posterior Cervical Fixation
• Version Model Number: 6118-5046
• 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	08809986479242 [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

[08809986479242]

Moist Heat or Steam Sterilization

[08809986479242]

Moist Heat or Steam Sterilization

[08809986479242]

Moist Heat or Steam Sterilization

[08809986479242]

Moist Heat or Steam Sterilization

[08809986479242]

Moist Heat or Steam Sterilization

[08809986479242]

Moist Heat or Steam Sterilization

[08809986479242]

Moist Heat or Steam Sterilization

[08809986479242]

Moist Heat or Steam Sterilization

[08809986479242]

Moist Heat or Steam Sterilization

[08809986479242]

Moist Heat or Steam Sterilization

[08809986479242]

Moist Heat or Steam Sterilization

[08809986479242]

Moist Heat or Steam Sterilization

[08809986479242]

Moist Heat or Steam Sterilization

[08809986479242]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-18
• Device Publish Date: 2025-04-10

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

• 08809986478566: Partially Poly Axial Screw 4.5X46mm
• 08809986478559: Partially Poly Axial Screw 4.5X44mm
• 08809986478542: Partially Poly Axial Screw 4.5X42mm
• 08809986478535: Partially Poly Axial Screw 4.5X40mm
• 08809986478528: Partially Poly Axial Screw 4.5X38mm
• 08809986478511: Partially Poly Axial Screw 4.5X36mm
• 08809986478504: Partially Poly Axial Screw 4.5X34mm
• 08809986478498: Partially Poly Axial Screw 4.5X32mm
• 08809986478481: Partially Poly Axial Screw 4.5X30mm
• 08809986478474: Partially Poly Axial Screw 4.5X28mm
• 08809986478467: Partially Poly Axial Screw 4.5X26mm
• 08809986478450: Partially Poly Axial Screw 4.5X24mm
• 08809986478443: Partially Poly Axial Screw 4.5X22mm
• 08809986478436: Partially Poly Axial Screw 4.5X20mm
• 08809986478429: Partially Poly Axial Screw 4.5X18mm
• 08809986478412: Semi Poly Screw 5.5X50mm
• 08809986478405: Semi Poly Screw 5.5X48mm
• 08809986478399: Semi Poly Screw 5.5X46mm
• 08809986478382: Semi Poly Screw 5.5X44mm
• 08809986478375: Semi Poly Screw 5.5X42mm
• 08809986478368: Semi Poly Screw 5.5X40mm
• 08809986478351: Semi Poly Screw 5.5X38mm
• 08809986478344: Semi Poly Screw 5.5X36mm
• 08809986478337: Semi Poly Screw 5.5X34mm
• 08809986478320: Semi Poly Screw 5.5X32mm
• 08809986478313: Semi Poly Screw 5.5X30mm
• 08809986478306: Semi Poly Screw 5.5X28mm
• 08809986478290: Semi Poly Screw 5.5X26mm
• 08809986478283: Semi Poly Screw 5.5X24mm
• 08809986478276: Semi Poly Screw 5.5X22mm
• 08809986478269: Semi Poly Screw 5.5X20mm
• 08809986478252: Semi Poly Screw 5.5X18mm
• 08809986478245: Semi Poly Screw 5.5X16mm
• 08809986478238: Semi Poly Screw 5.5X14mm
• 08809986478221: Semi Poly Screw 5.5X12mm
• 08809986478214: Semi Poly Screw 5.5X10mm
• 08809986478207: Semi Poly Screw 5.0X50mm
• 08809986478191: Semi Poly Screw 5.0X48mm
• 08809986478184: Semi Poly Screw 5.0X46mm
• 08809986478177: Semi Poly Screw 5.0X44mm
• 08809986478160: Semi Poly Screw 5.0X42mm
• 08809986478153: Semi Poly Screw 5.0X40mm
• 08809986478146: Semi Poly Screw 5.0X38mm
• 08809986478139: Semi Poly Screw 5.0X36mm
• 08809986478122: Semi Poly Screw 5.0X34mm
• 08809986478115: Semi Poly Screw 5.0X32mm
• 08809986478108: Semi Poly Screw 5.0X30mm
• 08809986478092: Semi Poly Screw 5.0X28mm
• 08809986478085: Semi Poly Screw 5.0X26mm
• 08809986478078: Semi Poly Screw 5.0X24mm