FDA.reportPublic FDA data

TAURUS PEEK Cage System

Primary DI
08809596876103
Brand
TAURUS PEEK Cage System
Company
Medyssey Co., Ltd.
Model
DP65511A
Device description
TAURUS PEEK Cage System, Taurus-DL type, Non-sterile type, 6° 11x55x20mm
Published
2017-12-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170389000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170389000TAURUS PEEK Cage SystemMedyssey USA, Inc.2017-12-14MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809596876103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809596876103088095968761038809596876103

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
688211503
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806364689439Kora Spinal SystemMHP65202026-10-01
08806364690077Kora Spinal SystemMHP85252026-10-01
08809974423714Hedjet SystemDZRHHPS601002026-10-01
08809974435823Hedjet System13DZRPS60452026-10-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800322691458Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08800322691533Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08800322691540Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08800322691557Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08800322691564Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08800322691571Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08800322691588Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08800322691595Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08800322691601Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861110Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861127Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861134Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861295Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861301Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861318Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861325Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861332Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861349Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861356Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861363Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861370Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861387Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861394Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861400Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861424Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861431Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861448Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861455Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861462Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861479Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19