Mecta-C Cervical Plate System

GUDID 07630030840395

Variable self-tapping screw diam. 4x20mm (2x)

Medacta International SA

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 07630030840395
• NIH Device Record Key: 8cdff04a-e7f8-4e99-9d4a-e938dab27d96
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mecta-C Cervical Plate System
• Version Model Number: 03.70.061
• Company DUNS: 488227125
• Company Name: Medacta International SA
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630030840395 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140361

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-09
• Device Publish Date: 2015-10-18

On-Brand Devices [Mecta-C Cervical Plate System]

• 07630030842726: Unsterile Cervical Plate L4x92mm
• 07630030842719: Unsterile Cervical Plate L4x88mm
• 07630030842702: Unsterile Cervical Plate L4x84mm
• 07630030842696: Unsterile Cervical Plate L4x80mm
• 07630030842689: Unsterile Cervical Plate L4x76mm
• 07630030842672: Unsterile Cervical Plate L4x72mm
• 07630030842665: Unsterile Cervical Plate L4x68mm
• 07630030842658: Unsterile fixed self-tapping screw diam. 4.5x22mm
• 07630030842641: Unsterile fixed self-tapping screw diam. 4.5x20mm
• 07630030842634: Unsterile fixed self-tapping screw diam. 4.5x18mm
• 07630030842627: Unsterile fixed self-tapping screw diam. 4.5x16mm
• 07630030842610: Unsterile fixed self-tapping screw diam. 4.5x14mm
• 07630030842603: Unsterile fixed self-tapping screw diam. 4.5x12mm
• 07630030842597: Unsterile Cervical Plate L3x76mm
• 07630030842580: Unsterile Cervical Plate L3x73mm
• 07630030842573: Unsterile Cervical Plate L3x70mm
• 07630030842566: Unsterile Cervical Plate L3x67mm
• 07630030842559: Unsterile Cervical Plate L3x64mm
• 07630030842542: Unsterile Cervical Plate L3x61mm
• 07630030842535: Unsterile Cervical Plate L3x58mm
• 07630030842528: Unsterile Cervical Plate L3x55mm
• 07630030842511: Unsterile Cervical Plate L3x52mm
• 07630030842504: Unsterile fixed self-tapping screw diam. 4x22mm
• 07630030842498: Unsterile fixed self-tapping screw diam. 4x21mm
• 07630030842481: Unsterile fixed self-tapping screw diam. 4x20mm
• 07630030842474: Unsterile fixed self-tapping screw diam. 4x19mm
• 07630030842467: Unsterile fixed self-tapping screw diam. 4x18mm
• 07630030842450: Unsterile fixed self-tapping screw diam. 4x17mm
• 07630030842443: Unsterile fixed self-tapping screw diam. 4x16mm
• 07630030842436: Unsterile fixed self-tapping screw diam. 4x15mm
• 07630030842429: Unsterile fixed self-tapping screw diam. 4x14mm
• 07630030842412: Unsterile fixed self-tapping screw diam. 4x13mm
• 07630030842405: Unsterile fixed self-tapping screw diam. 4x12mm
• 07630030842399: Unsterile Cervical Plate L2x52mm
• 07630030842382: Unsterile Cervical Plate L2x49mm
• 07630030842375: Unsterile Cervical Plate L2x46mm
• 07630030842368: Unsterile Cervical Plate L2x43mm
• 07630030842351: Unsterile Cervical Plate L2x40mm
• 07630030842344: Unsterile Cervical Plate L2x37mm
• 07630030842337: Unsterile Cervical Plate L2x34mm
• 07630030842320: Unsterile fixed self-drilling screw diam. 4x22mm
• 07630030842313: Unsterile fixed self-drilling screw diam. 4x21mm
• 07630030842306: Unsterile fixed self-drilling screw diam. 4x20mm
• 07630030842290: Unsterile fixed self-drilling screw diam. 4x19mm
• 07630030842283: Unsterile fixed self-drilling screw diam. 4x18mm
• 07630030842276: Unsterile fixed self-drilling screw diam. 4x17mm
• 07630030842269: Unsterile fixed self-drilling screw diam. 4x16mm
• 07630030842252: Unsterile fixed self-drilling screw diam. 4x15mm
• 07630030842245: Unsterile fixed self-drilling screw diam. 4x14mm
• 07630030842238: Unsterile fixed self-drilling screw diam. 4x13mm