Paeon Anterior Cervical Plate System 6601-3518

GUDID 00840273303404

Fixed Cervical Plate Screw Self Tapping, Star, Cylindrical Ø 3.5, 18mm

Aegis Spine, Inc.

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 00840273303404
• NIH Device Record Key: 6c7ca69a-9244-46e8-bbd8-b222de61cef1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Paeon Anterior Cervical Plate System
• Version Model Number: 6601-3518
• Catalog Number: 6601-3518
• 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: 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	00840273303404 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210035

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

[00840273303404]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-27
• Device Publish Date: 2022-04-19

On-Brand Devices [Paeon Anterior Cervical Plate System]

• 00840273303374: Fixed Cervical Plate Screw Self Tapping, Star, Cylindrical Ø 3.5, 15mm
• 00840273303367: Fixed Cervical Plate Screw Self Tapping, Star, Cylindrical Ø 3.5, 14mm
• 00840273303350: Fixed Cervical Plate Screw Self Tapping, Star, Cylindrical Ø 3.5, 13mm
• 00840273303343: Fixed Cervical Plate Screw Self Tapping, Star, Cylindrical Ø 3.5, 12mm
• 00840273303336: Fixed Cervical Plate Screw Self Tapping, Star, Cylindrical Ø 3.5, 11mm
• 00840273303329: Fixed Cervical Plate Screw Self Tapping, Star, Cylindrical Ø 3.5, 10mm
• 00840273303312: Cervical Plate Contour Type 4 Level 97mm
• 00840273303305: Cervical Plate Contour Type 4 Level 93mm
• 00840273303299: Cervical Plate Contour Type 4 Level 89mm
• 00840273303282: Cervical Plate Contour Type 4 Level 85mm
• 00840273303275: Cervical Plate Contour Type 4 Level 81mm
• 00840273303268: Cervical Plate Contour Type 4 Level 77mm
• 00840273303251: Cervical Plate Contour Type 4 Level 73mm
• 00840273303244: Cervical Plate Contour Type 4 Level 69mm
• 00840273303237: Cervical Plate Contour Type 4 Level 65mm
• 00840273303220: Cervical Plate Contour Type 3 Level 72mm
• 00840273303213: Cervical Plate Contour Type 3 Level 69mm
• 00840273303206: Cervical Plate Contour Type 3 Level 66mm
• 00840273303190: Cervical Plate Contour Type 3 Level 63mm
• 00840273303183: Cervical Plate Contour Type 3 Level 60mm
• 00840273303176: Cervical Plate Contour Type 3 Level 57mm
• 00840273303169: Cervical Plate Contour Type 3 Level 54mm
• 00840273303152: Cervical Plate Contour Type 3 Level 51mm
• 00840273303145: Cervical Plate Contour Type 3 Level 48mm
• 00840273303138: Cervical Plate Contour Type 2 Level 51mm
• 00840273303121: Cervical Plate Contour Type 2 Level 49mm
• 00840273303114: Cervical Plate Contour Type 2 Level 47mm
• 00840273303107: Cervical Plate Contour Type 2 Level 45mm
• 00840273303091: Cervical Plate Contour Type 2 Level 43mm
• 00840273303084: Cervical Plate Contour Type 2 Level 41mm
• 00840273303077: Cervical Plate Contour Type 2 Level 39mm
• 00840273303060: Cervical Plate Contour Type 2 Level 37mm
• 00840273303053: Cervical Plate Contour Type 2 Level 35mm
• 00840273303046: Cervical Plate Contour Type 1 Level 35mm
• 00840273303039: Cervical Plate Contour Type 1 Level 33mm
• 00840273303022: Cervical Plate Contour Type 1 Level 31mm
• 00840273303015: Cervical Plate Contour Type 1 Level 29mm
• 00840273303008: Cervical Plate Contour Type 1 Level 27mm
• 00840273302995: Cervical Plate Contour Type 1 Level 25mm
• 00840273302988: Cervical Plate Contour Type 1 Level 23mm
• 00840273302971: Cervical Plate Contour Type 1 Level 21mm
• 00840273302964: Cervical Plate Contour Type 1 Level 19mm
• 00840273303916: Fixed Cervical Plate Screw Self Drilling, Star, Conical Ø 3.5, 17mm
• 00840273303909: Fixed Cervical Plate Screw Self Drilling, Star, Conical Ø 3.5, 16mm
• 00840273303893: Fixed Cervical Plate Screw Self Drilling, Star, Conical Ø 3.5, 15mm
• 00840273303886: Fixed Cervical Plate Screw Self Drilling, Star, Conical Ø 3.5, 14mm
• 00840273303879: Fixed Cervical Plate Screw Self Drilling, Star, Conical Ø 3.5, 13mm
• 00840273303862: Fixed Cervical Plate Screw Self Drilling, Star, Conical Ø 3.5, 12mm
• 00840273303855: Fixed Cervical Plate Screw Self Drilling, Star, Conical Ø 3.5, 11mm
• 00840273303848: Fixed Cervical Plate Screw Self Drilling, Star, Conical Ø 3.5, 10mm