FDA.reportPublic FDA data

Zenius Spinal System

Primary DI
08800048455471
Brand
Zenius Spinal System
Company
Medyssey Co., Ltd.
Model
SPO8530
Device description
Polyaxial Pedicle Screw, Ø8.5mm X 30.0mm , Ø5.5 Rod
Published
2016-09-22
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
KWQAppliance, Fixation, Spinal Intervertebral Body
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800048455471PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800048455471088000484554718800048455471

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017913664Saber-C Body (PT), 12x15x7 6 deg.ELEVATION SPINE, INC.KWQ2026-06-05
00810017914609Saber-C Plate, 14x17x6 12 deg.ELEVATION SPINE, INC.KWQ2026-06-05
00810017914616Saber-C Plate, 14x17x7 12 deg.ELEVATION SPINE, INC.KWQ2026-06-05
00810017914623Saber-C Plate, 14x17x8 12 deg.ELEVATION SPINE, INC.KWQ2026-06-05
00810017915354Saber-C, Spike Driver 5-7, MedialELEVATION SPINE, INC.KWQ2026-06-05
00810017915361Saber-C, Spike Driver 5-7, LateralELEVATION SPINE, INC.KWQ2026-06-05
00810017915378Saber-C, Spike Driver 8-9, MedialELEVATION SPINE, INC.KWQ2026-06-05
00810017915385Saber-C, Spike Driver 8-9, LateralELEVATION SPINE, INC.KWQ2026-06-05
00840283407949VyPlate™VY SPINE LLCKWQ2026-06-05
00840493422596RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422602RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422619RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422626RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422633RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422640RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422657RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422664RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422671RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422688RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422695RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422701RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422718RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422725RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422732RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422749RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422756RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422763RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422770RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422787RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422794RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05