CastleLoc-P Anterior Cervical Plate System 6604-4016

GUDID 08806189895039

CastleLoc-P Anterior Cervical Plate Screw(Self Drilling, Variable, Star) 4.0x16mm 1EA

L&K BIOMED CO. ,LTD.

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 08806189895039
• NIH Device Record Key: 90cf95d8-6255-4e00-9a0c-075355a6fa55
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CastleLoc-P Anterior Cervical Plate System
• Version Model Number: 6604-4016
• Catalog Number: 6604-4016
• 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	08806189895039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143271

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[08806189895039]

Moist Heat or Steam Sterilization

[08806189895039]

Moist Heat or Steam Sterilization

[08806189895039]

Moist Heat or Steam Sterilization

[08806189895039]

Moist Heat or Steam Sterilization

[08806189895039]

Moist Heat or Steam Sterilization

[08806189895039]

Moist Heat or Steam Sterilization

[08806189895039]

Moist Heat or Steam Sterilization

[08806189895039]

Moist Heat or Steam Sterilization

[08806189895039]

Moist Heat or Steam Sterilization

[08806189895039]

Moist Heat or Steam Sterilization

[08806189895039]

Moist Heat or Steam Sterilization

[08806189895039]

Moist Heat or Steam Sterilization

[08806189895039]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-09-18
• Device Publish Date: 2015-07-30

On-Brand Devices [CastleLoc-P Anterior Cervical Plate System]

• 08809649610654: CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Variable, Star) 3.5x11mm 1EA
• 08809649610647: CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Variable, Star) 3.5x10mm 1EA
• 08809649610630: CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 4.0x22mm 1EA
• 08809649610623: CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 4.0x21mm 1EA
• 08809649610616: CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 4.0x20mm 1EA
• 08809649610609: CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 4.0x19mm 1EA
• 08809649610593: CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 4.0x18mm 1EA
• 08809649610586: CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 4.0x17mm 1EA
• 08809649610579: CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 4.0x16mm 1EA
• 08809649610562: CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 4.0x15mm 1EA
• 08809649610555: CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 4.0x14mm 1EA
• 08809649610548: CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 4.0x13mm 1EA
• 08809649610531: CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 4.0x12mm 1EA
• 08809649610524: CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 4.0x11mm 1EA
• 08809649610517: CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 4.0x10mm 1EA
• 08809649610500: CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 3.5x22mm 1EA
• 08809649610494: CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 3.5x21mm 1EA
• 08809649610487: CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 3.5x20mm 1EA
• 08809649610470: CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 3.5x19mm 1EA
• 08809649610463: CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 3.5x18mm 1EA
• 08809649610456: CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 3.5x17mm 1EA
• 08809649610449: CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 3.5x16mm 1EA
• 08809649610432: CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 3.5x15mm 1EA
• 08809649610425: CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 3.5x14mm 1EA
• 08809649610418: CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 3.5x13mm 1EA
• 08809649610401: CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 3.5x12mm 1EA
• 08809649610395: CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 3.5x11mm 1EA
• 08809649610388: CastleLoc-P Anterior Cervical Plate Screw(Self Tapping, Fixed, Star) 3.5x10mm 1EA
• 08809649610371: CastleLoc-P Anterior Cervical Plate (4Level-Contour Type) 97mm 1EA
• 08809649610364: CastleLoc-P Anterior Cervical Plate (4Level-Contour Type) 93mm 1EA
• 08809649610357: CastleLoc-P Anterior Cervical Plate (4Level-Contour Type) 89mm 1EA
• 08809649610340: CastleLoc-P Anterior Cervical Plate (4Level-Contour Type) 85mm 1EA
• 08809649610333: CastleLoc-P Anterior Cervical Plate (4Level-Contour Type) 81mm 1EA
• 08809649610326: CastleLoc-P Anterior Cervical Plate (4Level-Contour Type) 77mm 1EA
• 08809649610319: CastleLoc-P Anterior Cervical Plate (4Level-Contour Type) 73mm 1EA
• 08809649610302: CastleLoc-P Anterior Cervical Plate (4Level-Contour Type) 69mm 1EA
• 08809649610296: CastleLoc-P Anterior Cervical Plate (4Level-Contour Type) 65mm 1EA
• 08809649610289: CastleLoc-P Anterior Cervical Plate (3Level-Contour Type) 72mm 1EA
• 08809649610272: CastleLoc-P Anterior Cervical Plate (3Level-Contour Type) 69mm 1EA
• 08809649610265: CastleLoc-P Anterior Cervical Plate (3Level-Contour Type) 66mm 1EA
• 08809649610258: CastleLoc-P Anterior Cervical Plate (3Level-Contour Type) 63mm 1EA
• 08809649610241: CastleLoc-P Anterior Cervical Plate (3Level-Contour Type) 60mm 1EA
• 08809649610234: CastleLoc-P Anterior Cervical Plate (3Level-Contour Type) 57mm 1EA
• 08809649610227: CastleLoc-P Anterior Cervical Plate (3Level-Contour Type) 54mm 1EA
• 08809649610210: CastleLoc-P Anterior Cervical Plate (3Level-Contour Type) 51mm 1EA
• 08809649610203: CastleLoc-P Anterior Cervical Plate (3Level-Contour Type) 48mm 1EA
• 08809649610197: CastleLoc-P Anterior Cervical Plate (2Level-Contour Type) 51mm 1EA
• 08809649610180: CastleLoc-P Anterior Cervical Plate (2Level-Contour Type) 49mm 1EA
• 08809649610173: CastleLoc-P Anterior Cervical Plate (2Level-Contour Type) 47mm 1EA
• 08809649610166: CastleLoc-P Anterior Cervical Plate (2Level-Contour Type) 45mm 1EA