Athena Cervical Plate System

GUDID 08809625989910

Variable & Fixed Angle Type Plate, 1-Level, 20mm

Medyssey Co., Ltd.

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable
Primary Device ID08809625989910
NIH Device Record Key34943ced-8992-474b-ade2-0814ade23e4d
Commercial Distribution StatusIn Commercial Distribution
Brand NameAthena Cervical Plate System
Version Model NumberAPJ20
Company DUNS688211503
Company NameMedyssey Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809625989910 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809625989910]

Moist Heat or Steam Sterilization

[08809625989910]

Moist Heat or Steam Sterilization

[08809625989910]

Moist Heat or Steam Sterilization

[08809625989910]

Moist Heat or Steam Sterilization

[08809625989910]

Moist Heat or Steam Sterilization

[08809625989910]

Moist Heat or Steam Sterilization

[08809625989910]

Moist Heat or Steam Sterilization

[08809625989910]

Moist Heat or Steam Sterilization

[08809625989910]

Moist Heat or Steam Sterilization

[08809625989910]

Moist Heat or Steam Sterilization

[08809625989910]

Moist Heat or Steam Sterilization

[08809625989910]

Moist Heat or Steam Sterilization

[08809625989910]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-09-18
Device Publish Date2018-10-24

On-Brand Devices [Athena Cervical Plate System]

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