CastleLoc-C Cervical Interbody Fusion Cage System 5105-1517

GUDID 08806344362901

Cervical Cage 15, 17, 05mm 0°

L&K BIOMED CO. ,LTD.

Polymeric spinal interbody fusion cage

• Primary Device ID: 08806344362901
• NIH Device Record Key: d430806a-e23a-4514-9a2f-6457417a82bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CastleLoc-C Cervical Interbody Fusion Cage System
• Version Model Number: 5105-1517
• Catalog Number: 5105-1517
• 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	08806344362901 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151677

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[08806344362901]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2017-09-20

On-Brand Devices [CastleLoc-C Cervical Interbody Fusion Cage System]

• 08806344363014: Cervical Cage 15, 19, 10mm 0°
• 08806344363007: Cervical Cage 15, 19, 09mm 0°
• 08806344362994: Cervical Cage 15, 19, 08mm 0°
• 08806344362987: Cervical Cage 15, 19, 07mm 0°
• 08806344362970: Cervical Cage 15, 19, 06mm 0°
• 08806344362963: Cervical Cage 15, 19, 05mm 0°
• 08806344362956: Cervical Cage 15, 17, 10mm 0°
• 08806344362949: Cervical Cage 15, 17, 09mm 0°
• 08806344362932: Cervical Cage 15, 17, 08mm 0°
• 08806344362925: Cervical Cage 15, 17, 07mm 0°
• 08806344362918: Cervical Cage 15, 17, 06mm 0°
• 08806344362901: Cervical Cage 15, 17, 05mm 0°
• 08806344362895: Cervical Cage 15, 15, 10mm 0°
• 08806344362888: Cervical Cage 15, 15, 09mm 0°
• 08806344362871: Cervical Cage 15, 15, 08mm 0°
• 08806344362864: Cervical Cage 15, 15, 07mm 0°
• 08806344362857: Cervical Cage 15, 15, 06mm 0°
• 08806344362840: Cervical Cage 15, 15, 05mm 0°
• 08806344362833: Cervical Cage 14, 19, 10mm 0°
• 08806344362826: Cervical Cage 14, 19, 09mm 0°
• 08806344362819: Cervical Cage 14, 19, 08mm 0°
• 08806344362802: Cervical Cage 14, 19, 07mm 0°
• 08806344362796: Cervical Cage 14, 19, 06mm 0°
• 08806344362789: Cervical Cage 14, 19, 05mm 0°
• 08806344362772: Cervical Cage 14, 17, 10mm 0°
• 08806344362765: Cervical Cage 14, 17, 09mm 0°
• 08806344362758: Cervical Cage 14, 17, 08mm 0°
• 08806344362741: Cervical Cage 14, 17, 07mm 0°
• 08806344362734: Cervical Cage 14, 17, 06mm 0°
• 08806344362727: Cervical Cage 14, 17, 05mm 0°
• 08806344362710: Cervical Cage 14, 14, 10mm 0°
• 08806344362703: Cervical Cage 14, 14, 09mm 0°
• 08806344362697: Cervical Cage 14, 14, 08mm 0°
• 08806344362680: Cervical Cage 14, 14, 07mm 0°
• 08806344362673: Cervical Cage 14, 14, 06mm 0°
• 08806344362666: Cervical Cage 14, 14, 05mm 0°
• 08806344362659: Cervical Cage 13, 15, 10mm 0°
• 08806344362642: Cervical Cage 13, 15, 09mm 0°
• 08806344362635: Cervical Cage 13, 15, 08mm 0°
• 08806344362628: Cervical Cage 13, 15, 07mm 0°
• 08806344362611: Cervical Cage 13, 15, 06mm 0°
• 08806344362604: Cervical Cage 13, 15, 05mm 0°
• 08806344362598: Cervical Cage 12, 17, 10mm 0°
• 08806344362581: Cervical Cage 12, 17, 09mm 0°
• 08806344362574: Cervical Cage 12, 17, 08mm 0°
• 08806344362567: Cervical Cage 12, 17, 07mm 0°
• 08806344362550: Cervical Cage 12, 17, 06mm 0°
• 08806344362543: Cervical Cage 12, 17, 05mm 0°
• 08806344362536: Cervical Cage 12, 14, 10mm 0°
• 08806344362529: Cervical Cage 12, 14, 09mm 0°