FDA.reportPublic FDA data

Athena II Cervical Plate System

Primary DI
08800048413938
Brand
Athena II Cervical Plate System
Company
Medyssey Co., Ltd.
Model
APS4014WS
Device description
Athena II Screw - Self Drilling Ø4.0x14mm
Published
2019-07-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183409000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183409000Athena II Cervical Plate SystemMedyssey USA, Inc.2019-02-11KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800048413938PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800048413938088000484139388800048413938

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small implantable sheet of solid material that is attached to the spine with screws for spinal immobilization and is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
688211503
Device count
1
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800311596863NAPNPS-0032026-03-12
08800311596696NANNSS-0022026-03-09
08800311596665NANXVC-0022026-02-19
08800311596474Medyssey Poseidon OCT Spinal Fixation SystemR350552026-01-30
08800311596481Medyssey Poseidon OCT Spinal Fixation SystemR350652026-01-30
08800311596498Medyssey Poseidon OCT Spinal Fixation SystemR350752026-01-30
08800311596504Medyssey Poseidon OCT Spinal Fixation SystemR350852026-01-30
08800311596511Medyssey Poseidon OCT Spinal Fixation SystemR350952026-01-30
08800311596528Medyssey Poseidon OCT Spinal Fixation SystemR351052026-01-30
08800311596535Medyssey Poseidon OCT Spinal Fixation SystemR351152026-01-30
08800311596542Medyssey Poseidon OCT Spinal Fixation SystemR351252026-01-30
08800311596559Medyssey Poseidon OCT Spinal Fixation SystemR351352026-01-30
08800311596566Medyssey Poseidon OCT Spinal Fixation SystemR351452026-01-30
08800311596573Medyssey Poseidon OCT Spinal Fixation SystemR351552026-01-30
08800311596580Medyssey Poseidon OCT Spinal Fixation SystemR351652026-01-31
08800311596597Medyssey Poseidon OCT Spinal Fixation SystemR351752026-01-30
08800311596603Medyssey Poseidon OCT Spinal Fixation SystemR351852026-01-30
08800311596610Medyssey Poseidon OCT Spinal Fixation SystemR351952026-01-30
08800048442150NANAFI-1052025-02-26
08800048442204NANABP-0012025-02-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840311263042Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263059Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263066Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263073Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263080Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263097Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263103Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263110Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263127Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263134Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263141Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263158Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263165Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263172Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263189Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263196Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263202Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263219Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263226Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263233Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263240Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263257Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263264Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263271Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263288Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263295Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263301Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263318Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263325Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263332Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02