FDA.reportPublic FDA data

Hedjet System

Primary DI
08800048449890
Brand
Hedjet System
Company
Medyssey Co., Ltd.
Model
DZRPS7060
Device description
Hedjet Reduction Poly axial Screw 7.0x60mm, Ø5.5mm Rod
Published
2021-10-08
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
MNIOrthosis, Spinal Pedicle Fixation
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232218000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232218000Zenius™ Spinal SystemMedyssey USA, Inc.2023-08-24NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800048449890PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800048449890088000484498908800048449890

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
00840493423166RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423173RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423180RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423197RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423203RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423210RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423227RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423234RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423241RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423258RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423265RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423272RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423289RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423296RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423302RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423319RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423326RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423333RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423340RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423357RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423364RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423371RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423388RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423395RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423401RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423418RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423425RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423432RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423449RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423456RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08