Athena III Cervical Plate System

GUDID 08800048447056

Atena III Screw - Self Drilling Ø3.5x18mm

Medyssey Co., Ltd.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 08800048447056
• NIH Device Record Key: d7232efc-c961-4000-87b5-8a3b61ba1974
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Athena III Cervical Plate System
• Version Model Number: APS3518WWS
• Company DUNS: 688211503
• Company Name: Medyssey 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	08800048447056 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183409
• Premarket Notification: K230301

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[08800048447056]

Moist Heat or Steam Sterilization

[08800048447056]

Moist Heat or Steam Sterilization

[08800048447056]

Moist Heat or Steam Sterilization

[08800048447056]

Moist Heat or Steam Sterilization

[08800048447056]

Moist Heat or Steam Sterilization

[08800048447056]

Moist Heat or Steam Sterilization

[08800048447056]

Moist Heat or Steam Sterilization

[08800048447056]

Moist Heat or Steam Sterilization

[08800048447056]

Moist Heat or Steam Sterilization

[08800048447056]

Moist Heat or Steam Sterilization

[08800048447056]

Moist Heat or Steam Sterilization

[08800048447056]

Moist Heat or Steam Sterilization

[08800048447056]

Moist Heat or Steam Sterilization

[08800048447056]

Moist Heat or Steam Sterilization

[08800048447056]

Moist Heat or Steam Sterilization

[08800048447056]

Moist Heat or Steam Sterilization

[08800048447056]

Moist Heat or Steam Sterilization

[08800048447056]

Moist Heat or Steam Sterilization

[08800048447056]

Moist Heat or Steam Sterilization

[08800048447056]

Moist Heat or Steam Sterilization

[08800048447056]

Moist Heat or Steam Sterilization

[08800048447056]

Moist Heat or Steam Sterilization

[08800048447056]

Moist Heat or Steam Sterilization

[08800048447056]

Moist Heat or Steam Sterilization

[08800048447056]

Moist Heat or Steam Sterilization

[08800048447056]

Moist Heat or Steam Sterilization

[08800048447056]

Moist Heat or Steam Sterilization

[08800048447056]

Moist Heat or Steam Sterilization

[08800048447056]

Moist Heat or Steam Sterilization

[08800048447056]

Moist Heat or Steam Sterilization

[08800048447056]

Moist Heat or Steam Sterilization

[08800048447056]

Moist Heat or Steam Sterilization

[08800048447056]

Moist Heat or Steam Sterilization

[08800048447056]

Moist Heat or Steam Sterilization

[08800048447056]

Moist Heat or Steam Sterilization

[08800048447056]

Moist Heat or Steam Sterilization

[08800048447056]

Moist Heat or Steam Sterilization

[08800048447056]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-16
• Device Publish Date: 2021-08-06

On-Brand Devices [Athena III Cervical Plate System]

• 08800048447827: Atena III Screw - Self Drilling Ø4.0x20mm
• 08800048447810: Atena III Screw - Self Drilling Ø4.0x19mm
• 08800048447803: Atena III Screw - Self Drilling Ø4.0x17mm
• 08800048447797: Atena III Screw - Self Drilling Ø4.0x15mm
• 08800048447780: Atena III Screw - Self Drilling Ø4.0x13mm
• 08800048447773: Atena III Screw - Self Drilling Ø4.0x11mm
• 08800048447766: Atena III Screw - Self Drilling Ø3.5x20mm
• 08800048447759: Atena III Screw - Self Drilling Ø3.5x19mm
• 08800048447742: Atena III Screw - Self Drilling Ø3.5x17mm
• 08800048447735: Atena III Screw - Self Drilling Ø3.5x15mm
• 08800048447728: Atena III Screw - Self Drilling Ø3.5x13mm
• 08800048447711: Atena III Screw - Self Drilling Ø3.5x11mm
• 08800048447704: Atena III Screw - Self Tapping Ø4.0x20mm
• 08800048447698: Atena III Screw - Self Tapping Ø4.0x19mm
• 08800048447681: Atena III Screw - Self Tapping Ø4.0x17mm
• 08800048447674: Atena III Screw - Self Tapping Ø4.0x15mm
• 08800048447667: Atena III Screw - Self Tapping Ø4.0x13mm
• 08800048447650: Atena III Screw - Self Tapping Ø4.0x11mm
• 08800048447643: Atena III Screw - Self Tapping Ø3.5x20mm
• 08800048447636: Atena III Screw - Self Tapping Ø3.5x19mm
• 08800048447629: Atena III Screw - Self Tapping Ø3.5x17mm
• 08800048447612: Atena III Screw - Self Tapping Ø3.5x15mm
• 08800048447605: Atena III Screw - Self Tapping Ø3.5x13mm
• 08800048447599: Atena III Screw - Self Tapping Ø3.5x11mm
• 08800048447582: Atena III Cervical Plate, 4-Levels, 119mm
• 08800048447575: Atena III Cervical Plate, 4-Levels, 116mm
• 08800048447568: Atena III Cervical Plate, 4-Levels, 113mm
• 08800048447551: Atena III Cervical Plate, 4-Levels, 110mm
• 08800048447544: Atena III Cervical Plate, 4-Levels, 107mm
• 08800048447537: Atena III Cervical Plate, 4-Levels, 104mm
• 08800048447520: Atena III Cervical Plate, 4-Levels, 101mm
• 08800048447513: Atena III Cervical Plate, 4-Levels, 98mm
• 08800048447506: Atena III Cervical Plate, 4-Levels, 95mm
• 08800048447490: Atena III Cervical Plate, 4-Levels, 92mm
• 08800048447483: Atena III Cervical Plate, 4-Levels, 89mm
• 08800048447476: Atena III Cervical Plate, 4-Levels, 86mm
• 08800048447469: Atena III Cervical Plate, 4-Levels, 83mm
• 08800048447452: Atena III Cervical Plate, 4-Levels, 80mm
• 08800048447445: Atena III Cervical Plate, 4-Levels, 77mm
• 08800048447438: Atena III Cervical Plate, 4-Levels, 74mm
• 08800048447421: Atena III Cervical Plate, 3-Levels, 77mm
• 08800048447414: Atena III Cervical Plate, 3-Levels, 74mm
• 08800048447407: Atena III Cervical Plate, 3-Levels, 71mm
• 08800048447391: Atena III Cervical Plate, 3-Levels, 68mm
• 08800048447384: Atena III Cervical Plate, 3-Levels, 65mm
• 08800048447377: Atena III Cervical Plate, 3-Levels, 62mm
• 08800048447360: Atena III Cervical Plate, 3-Levels, 59mm
• 08800048447353: Atena III Cervical Plate, 3-Levels, 56mm
• 08800048447346: Atena III Cervical Plate, 3-Levels, 53mm
• 08800048447339: Atena III Cervical Plate, 3-Levels, 50mm