FDA.reportPublic FDA data

BN Cage

Primary DI
08806364625499
Brand
BN Cage
Company
Medyssey Co., Ltd.
Model
BS01425
Device description
Medyssey PEEK Lumbar Cage, 25mm Length, 9mm Width, 14mm Height, 0-degrees Lordosis
Published
2016-09-12
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806364625499PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806364625499088063646254998806364625499

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

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
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

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Primary DI, Brand, Company table
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