MegaCerfix Anterior Cervical Plate System 6608-3519S

GUDID 00840273301233

Variable Cervical Plate Screw Self Drilling, Star, Conical Ø 3.5, 19mm

Aegis Spine, Inc.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00840273301233
• NIH Device Record Key: 0aa9c5f5-7dd9-440f-a4df-3597192c16d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MegaCerfix Anterior Cervical Plate System
• Version Model Number: 6608-3519S
• Catalog Number: 6608-3519S
• Company DUNS: 017993061
• Company Name: Aegis Spine, Inc.
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840273301233 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210035

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-20
• Device Publish Date: 2021-09-10

On-Brand Devices [MegaCerfix Anterior Cervical Plate System]

• 00840273300359: Cervical Plate Contour Type 4 Level 97mm
• 00840273300342: Cervical Plate Contour Type 4 Level 93mm
• 00840273300335: Cervical Plate Contour Type 4 Level 89mm
• 00840273300328: Cervical Plate Contour Type 4 Level 85mm
• 00840273300311: Cervical Plate Contour Type 4 Level 81mm
• 00840273300304: Cervical Plate Contour Type 4 Level 77mm
• 00840273300298: Cervical Plate Contour Type 4 Level 73mm
• 00840273300281: Cervical Plate Contour Type 4 Level 69mm
• 00840273300274: Cervical Plate Contour Type 4 Level 65mm
• 00840273300267: Cervical Plate Contour Type 3 Level 72mm
• 00840273300250: Cervical Plate Contour Type 3 Level 69mm
• 00840273300243: Cervical Plate Contour Type 3 Level 66mm
• 00840273300236: Cervical Plate Contour Type 3 Level 63mm
• 00840273300229: Cervical Plate Contour Type 3 Level 60mm
• 00840273300212: Cervical Plate Contour Type 3 Level 57mm
• 00840273300205: Cervical Plate Contour Type 3 Level 54mm
• 00840273300199: Cervical Plate Contour Type 3 Level 51mm
• 00840273300182: Cervical Plate Contour Type 3 Level 48mm
• 00840273300175: Cervical Plate Contour Type 2 Level 51mm
• 00840273300168: Cervical Plate Contour Type 2 Level 49mm
• 00840273300151: Cervical Plate Contour Type 2 Level 47mm
• 00840273300144: Cervical Plate Contour Type 2 Level 45mm
• 00840273300137: Cervical Plate Contour Type 2 Level 43mm
• 00840273300120: Cervical Plate Contour Type 2 Level 41mm
• 00840273300113: Cervical Plate Contour Type 2 Level 39mm
• 00840273300106: Cervical Plate Contour Type 2 Level 37mm
• 00840273300090: Cervical Plate Contour Type 2 Level 35mm
• 00840273300083: Cervical Plate Contour Type 1 Level 35mm
• 00840273300076: Cervical Plate Contour Type 1 Level 33mm
• 00840273300069: Cervical Plate Contour Type 1 Level 31mm
• 00840273300052: Cervical Plate Contour Type 1 Level 29mm
• 00840273300045: Cervical Plate Contour Type 1 Level 27mm
• 00840273300038: Cervical Plate Contour Type 1 Level 25mm
• 00840273300021: Cervical Plate Contour Type 1 Level 23mm
• 00840273300014: Cervical Plate Contour Type 1 Level 21mm
• 00840273300007: Cervical Plate Contour Type 1 Level 19mm
• 00840273300878: Variable Cervical Plate Screw Self Tapping, Star, Cylindrical Ø 4.0, 22mm
• 00840273300861: Variable Cervical Plate Screw Self Tapping, Star, Cylindrical Ø 4.0, 21mm
• 00840273300854: Variable Cervical Plate Screw Self Tapping, Star, Cylindrical Ø 4.0, 20mm
• 00840273300847: Variable Cervical Plate Screw Self Tapping, Star, Cylindrical Ø 4.0, 19mm
• 00840273300830: Variable Cervical Plate Screw Self Tapping, Star, Cylindrical Ø 4.0, 18mm
• 00840273300823: Variable Cervical Plate Screw Self Tapping, Star, Cylindrical Ø 4.0, 17mm
• 00840273300816: Variable Cervical Plate Screw Self Tapping, Star, Cylindrical Ø 4.0, 16mm
• 00840273300809: Variable Cervical Plate Screw Self Tapping, Star, Cylindrical Ø 4.0, 15mm
• 00840273300793: Variable Cervical Plate Screw Self Tapping, Star, Cylindrical Ø 4.0, 14mm
• 00840273300786: Variable Cervical Plate Screw Self Tapping, Star, Cylindrical Ø 4.0, 13mm
• 00840273300779: Variable Cervical Plate Screw Self Tapping, Star, Cylindrical Ø 4.0, 12mm
• 00840273300762: Variable Cervical Plate Screw Self Tapping, Star, Cylindrical Ø 4.0, 11mm
• 00840273300755: Variable Cervical Plate Screw Self Tapping, Star, Cylindrical Ø 4.0, 10mm
• 00840273300748: Variable Cervical Plate Screw Self Tapping, Star, Cylindrical Ø 3.5, 22mm