Athena II Cervical Plate System

GUDID 08800048413853

Athena II Screw - Self Drilling Ø3.5x17mm

Medyssey Co., Ltd.

Spinal fixation plate, non-bioabsorbable
Primary Device ID08800048413853
NIH Device Record Keya304fc40-5bcb-4a33-a096-0b688d5ea273
Commercial Distribution StatusIn Commercial Distribution
Brand NameAthena II Cervical Plate System
Version Model NumberAPS3517WS
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
GS108800048413853 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800048413853]

Moist Heat or Steam Sterilization

[08800048413853]

Moist Heat or Steam Sterilization

[08800048413853]

Moist Heat or Steam Sterilization

[08800048413853]

Moist Heat or Steam Sterilization

[08800048413853]

Moist Heat or Steam Sterilization

[08800048413853]

Moist Heat or Steam Sterilization

[08800048413853]

Moist Heat or Steam Sterilization

[08800048413853]

Moist Heat or Steam Sterilization

[08800048413853]

Moist Heat or Steam Sterilization

[08800048413853]

Moist Heat or Steam Sterilization

[08800048413853]

Moist Heat or Steam Sterilization

[08800048413853]

Moist Heat or Steam Sterilization

[08800048413853]

Moist Heat or Steam Sterilization

[08800048413853]

Moist Heat or Steam Sterilization

[08800048413853]

Moist Heat or Steam Sterilization

[08800048413853]

Moist Heat or Steam Sterilization

[08800048413853]

Moist Heat or Steam Sterilization

[08800048413853]

Moist Heat or Steam Sterilization

[08800048413853]

Moist Heat or Steam Sterilization

[08800048413853]

Moist Heat or Steam Sterilization

[08800048413853]

Moist Heat or Steam Sterilization

[08800048413853]

Moist Heat or Steam Sterilization

[08800048413853]

Moist Heat or Steam Sterilization

[08800048413853]

Moist Heat or Steam Sterilization

[08800048413853]

Moist Heat or Steam Sterilization

[08800048413853]

Moist Heat or Steam Sterilization

[08800048413853]

Moist Heat or Steam Sterilization

[08800048413853]

Moist Heat or Steam Sterilization

[08800048413853]

Moist Heat or Steam Sterilization

[08800048413853]

Moist Heat or Steam Sterilization

[08800048413853]

Moist Heat or Steam Sterilization

[08800048413853]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-17
Device Publish Date2019-07-09

On-Brand Devices [Athena II Cervical Plate System]

08800048413990Athena II Screw - Self Drilling Ø4.0x20mm
08800048413983Athena II Screw - Self Drilling Ø4.0x19mm
08800048413976Athena II Screw - Self Drilling Ø4.0x18mm
08800048413969Athena II Screw - Self Drilling Ø4.0x17mm
08800048413952Athena II Screw - Self Drilling Ø4.0x16mm
08800048413945Athena II Screw - Self Drilling Ø4.0x15mm
08800048413938Athena II Screw - Self Drilling Ø4.0x14mm
08800048413921Athena II Screw - Self Drilling Ø4.0x13mm
08800048413914Athena II Screw - Self Drilling Ø4.0x12mm
08800048413907Athena II Screw - Self Drilling Ø4.0x11mm
08800048413891Athena II Screw - Self Drilling Ø4.0x10mm
08800048413884Athena II Screw - Self Drilling Ø3.5x20mm
08800048413877Athena II Screw - Self Drilling Ø3.5x19mm
08800048413860Athena II Screw - Self Drilling Ø3.5x18mm
08800048413853Athena II Screw - Self Drilling Ø3.5x17mm
08800048413846Athena II Screw - Self Drilling Ø3.5x16mm
08800048413839Athena II Screw - Self Drilling Ø3.5x15mm
08800048413822Athena II Screw - Self Drilling Ø3.5x14mm
08800048413815Athena II Screw - Self Drilling Ø3.5x13mm
08800048413808Athena II Screw - Self Drilling Ø3.5x12mm
08800048413792Athena II Screw - Self Drilling Ø3.5x11mm
08800048413785Athena II Screw - Self Drilling Ø3.5x10mm
08800048413778Athena II Screw - Self Tapping Ø4.0x20mm
08800048413761Athena II Screw - Self Tapping Ø4.0x19mm
08800048413754Athena II Screw - Self Tapping Ø4.0x18mm
08800048413747Athena II Screw - Self Tapping Ø4.0x17mm
08800048413730Athena II Screw - Self Tapping Ø4.0x16mm
08800048413723Athena II Screw - Self Tapping Ø4.0x15mm
08800048413716Athena II Screw - Self Tapping Ø4.0x14mm
08800048413709Athena II Screw - Self Tapping Ø4.0x13mm
08800048413693Athena II Screw - Self Tapping Ø4.0x12mm
08800048413686Athena II Screw - Self Tapping Ø4.0x11mm
08800048413679Athena II Screw - Self Tapping Ø4.0x10mm
08800048413662Athena II Screw - Self Tapping Ø3.5x20mm
08800048413655Athena II Screw - Self Tapping Ø3.5x19mm
08800048413648Athena II Screw - Self Tapping Ø3.5x18mm
08800048413631Athena II Screw - Self Tapping Ø3.5x17mm
08800048413624Athena II Screw - Self Tapping Ø3.5x16mm
08800048413617Athena II Screw - Self Tapping Ø3.5x15mm
08800048413600Athena II Screw - Self Tapping Ø3.5x14mm
08800048413594Athena II Screw - Self Tapping Ø3.5x13mm
08800048413587Athena II Screw - Self Tapping Ø3.5x12mm
08800048413570Athena II Screw - Self Tapping Ø3.5x11mm
08800048413563Athena II Screw - Self Tapping Ø3.5x10mm
08800048413556Athena II Cervical Plate, 4-Levels, 119mm
08800048413549Athena II Cervical Plate, 4-Levels, 116mm
08800048413532Athena II Cervical Plate, 4-Levels, 113mm
08800048413525Athena II Cervical Plate, 4-Levels, 110mm
08800048413518Athena II Cervical Plate, 4-Levels, 107mm
08800048413501Athena II Cervical Plate, 4-Levels, 104mm
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