Athena Cervical Plate System

GUDID 08809625989996

Variable & Fixed Angle Type Plate, 1-Level, 36mm

Medyssey Co., Ltd.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 08809625989996
• NIH Device Record Key: e01f5de8-45da-4c4f-b98b-98a373f50369
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Athena Cervical Plate System
• Version Model Number: APJ36
• 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: false
• 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	08809625989996 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180022

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[08809625989996]

Moist Heat or Steam Sterilization

[08809625989996]

Moist Heat or Steam Sterilization

[08809625989996]

Moist Heat or Steam Sterilization

[08809625989996]

Moist Heat or Steam Sterilization

[08809625989996]

Moist Heat or Steam Sterilization

[08809625989996]

Moist Heat or Steam Sterilization

[08809625989996]

Moist Heat or Steam Sterilization

[08809625989996]

Moist Heat or Steam Sterilization

[08809625989996]

Moist Heat or Steam Sterilization

[08809625989996]

Moist Heat or Steam Sterilization

[08809625989996]

Moist Heat or Steam Sterilization

[08809625989996]

Moist Heat or Steam Sterilization

[08809625989996]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-09-18
• Device Publish Date: 2018-10-24

On-Brand Devices [Athena Cervical Plate System]

• 08809625989996: Variable & Fixed Angle Type Plate, 1-Level, 36mm
• 08809625989989: Variable & Fixed Angle Type Plate, 1-Level, 34mm
• 08809625989972: Variable & Fixed Angle Type Plate, 1-Level, 32mm
• 08809625989965: Variable & Fixed Angle Type Plate, 1-Level, 30mm
• 08809625989958: Variable & Fixed Angle Type Plate, 1-Level, 28mm
• 08809625989941: Variable & Fixed Angle Type Plate, 1-Level, 26mm
• 08809625989934: Variable & Fixed Angle Type Plate, 1-Level, 24mm
• 08809625989927: Variable & Fixed Angle Type Plate, 1-Level, 22mm
• 08809625989910: Variable & Fixed Angle Type Plate, 1-Level, 20mm
• 08800042402068: Locking screw - Self Drilling Ø4.5x20mm
• 08800042402051: Locking screw - Self Drilling Ø4.5x19mm
• 08800042402044: Locking screw - Self Drilling Ø4.5x18mm
• 08800042402037: Locking screw - Self Drilling Ø4.5x17mm
• 08800042402020: Locking screw - Self Drilling Ø4.5x16mm
• 08800042402013: Locking screw - Self Drilling Ø4.5x15mm
• 08800042402006: Locking screw - Self Drilling Ø4.5x14mm
• 08800042401993: Locking screw - Self Drilling Ø4.5x13mm
• 08800042401986: Locking screw - Self Drilling Ø4.5x12mm
• 08800042401979: Locking screw - Self Drilling Ø4.5x11mm
• 08800042401962: Locking screw - Self Drilling Ø4.5x10mm
• 08800042401955: Locking screw - Self Drilling Ø4.0x20mm
• 08800042401948: Locking screw - Self Drilling Ø4.0x19mm
• 08800042401931: Locking screw - Self Drilling Ø4.0x18mm
• 08800042401924: Locking screw - Self Drilling Ø4.0x17mm
• 08800042401917: Locking screw - Self Drilling Ø4.0x16mm
• 08800042401900: Locking screw - Self Drilling Ø4.0x15mm
• 08800042401894: Locking screw - Self Drilling Ø4.0x14mm
• 08800042401887: Locking screw - Self Drilling Ø4.0x13mm
• 08800042401870: Locking screw - Self Drilling Ø4.0x12mm
• 08800042401863: Locking screw - Self Drilling Ø4.0x11mm
• 08800042401856: Locking screw - Self Drilling Ø4.0x10mm
• 08800042401849: Locking screw Ø4.5x20mm
• 08800042401832: Locking screw Ø4.5x19mm
• 08800042401825: Locking screw Ø4.5x18mm
• 08800042401818: Locking screw Ø4.5x17mm
• 08800042401801: Locking screw Ø4.5x16mm
• 08800042401795: Locking screw Ø4.5x15mm
• 08800042401788: Locking screw Ø4.5x14mm
• 08800042401771: Locking screw Ø4.5x13mm
• 08800042401764: Locking screw Ø4.5x12mm
• 08800042401757: Locking screw Ø4.5x11mm
• 08800042401740: Locking screw Ø4.5x10mm
• 08800042401733: Locking screw Ø4.0x20mm
• 08800042401726: Locking screw Ø4.0x19mm
• 08800042401719: Locking screw Ø4.0x18mm
• 08800042401702: Locking screw Ø4.0x17mm
• 08800042401696: Locking screw Ø4.0x16mm
• 08800042401689: Locking screw Ø4.0x15mm
• 08800042401672: Locking screw Ø4.0x14mm
• 08800042401665: Locking screw Ø4.0x13mm