Zenius Spinal System

GUDID 08809625989460

Cannulated Poly-Axial Screw 5.0mm x 50mm, 5.5mm Rod, Long Reduction-Ø12mm Type

Medyssey Co., Ltd.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 08809625989460
• NIH Device Record Key: 3adf861e-dc2b-43d2-a53a-1d85450c6252
• Commercial Distribution Discontinuation: 2023-11-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Zenius Spinal System
• Version Model Number: ZSTXCP5050
• Company DUNS: 688211503
• Company Name: Medyssey Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809625989460 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171526

FDA Product Code

• NKB: Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08809625989460]

Moist Heat or Steam Sterilization

[08809625989460]

Moist Heat or Steam Sterilization

[08809625989460]

Moist Heat or Steam Sterilization

[08809625989460]

Moist Heat or Steam Sterilization

[08809625989460]

Moist Heat or Steam Sterilization

[08809625989460]

Moist Heat or Steam Sterilization

[08809625989460]

Moist Heat or Steam Sterilization

[08809625989460]

Moist Heat or Steam Sterilization

[08809625989460]

Moist Heat or Steam Sterilization

[08809625989460]

Moist Heat or Steam Sterilization

[08809625989460]

Moist Heat or Steam Sterilization

[08809625989460]

Moist Heat or Steam Sterilization

[08809625989460]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-02-16
• Device Publish Date: 2018-07-04

On-Brand Devices [Zenius Spinal System]

• 08809625987404: Reduction Polyaxial Pedicle Screw, Ø6.5mm X 60.0mm, Ø5.5 Rod
• 08809625980078: Cannulated Mono-Axial Screw 5.5mm x 55mm, 5.5mm Rod
• 08806364648306: Cannulated Poly-Axial Screw 8.5mm x 25mm, 5.5mm Rod
• 08806364648290: Cannulated Poly-Axial Screw 8.5mm x 20mm, 5.5mm Rod
• 08806364648283: Cannulated Poly-Axial Screw 8.0mm x 25mm, 5.5mm Rod
• 08806364648276: Cannulated Poly-Axial Screw 8.0mm x 20mm, 5.5mm Rod
• 08806364648269: Cannulated Poly-Axial Screw 7.5mm x 25mm, 5.5mm Rod
• 08806364648252: Cannulated Poly-Axial Screw 7.5mm x 20mm, 5.5mm Rod
• 08806364648245: Cannulated Poly-Axial Screw 7.0mm x 25mm, 5.5mm Rod
• 08806364648238: Cannulated Poly-Axial Screw 7.0mm x 20mm, 5.5mm Rod
• 08806364648221: Cannulated Poly-Axial Screw 6.5mm x 20mm, 5.5mm Rod
• 08806364648214: Cannulated Poly-Axial Screw 6.0mm x 20mm, 5.5mm Rod
• 08809625987787: Reduction Polyaxial Pedicle Screw, Ø7.5mm X 90.0mm, Ø5.5 Rod
• 08809625987152: Reduction Polyaxial Pedicle Screw, Ø5.5mm X 95.0mm, Ø5.5 Rod
• 08809625986575: Reduction Monoaxial Pedicle Screw, Ø9.5mm X 55.0mm, Ø5.5 Rod
• 08809625985042: Reduction Monoaxial Pedicle Screw, Ø4.5mm X 55.0mm, Ø5.5 Rod
• 08800048457574: Polyaxial Pedicle Screw, Ø9.5mm X 75.0mm , Ø5.5 Rod
• 08800048457567: Polyaxial Pedicle Screw, Ø9.5mm X 70.0mm , Ø5.5 Rod
• 08800048457550: Polyaxial Pedicle Screw, Ø9.5mm X 65.0mm , Ø5.5 Rod
• 08800048457536: Polyaxial Pedicle Screw, Ø9.5mm X 55.0mm , Ø5.5 Rod
• 08800048457529: Polyaxial Pedicle Screw, Ø9.5mm X 50.0mm , Ø5.5 Rod
• 08800048457512: Polyaxial Pedicle Screw, Ø9.5mm X 45.0mm , Ø5.5 Rod
• 08800048457505: Polyaxial Pedicle Screw, Ø9.5mm X 40.0mm , Ø5.5 Rod
• 08800048457499: Polyaxial Pedicle Screw, Ø9.5mm X 35.0mm , Ø5.5 Rod
• 08800048457482: Polyaxial Pedicle Screw, Ø9.5mm X 30.0mm , Ø5.5 Rod
• 08800048455471: Polyaxial Pedicle Screw, Ø8.5mm X 30.0mm , Ø5.5 Rod
• 08809625983369: Polyaxial Pedicle Screw, Ø6.5mm X 55.0mm , Ø5.5 Rod
• 08809625983321: Polyaxial Pedicle Screw, Ø6.5mm X 35.0mm , Ø5.5 Rod
• 08800048496191: Hole Poly-Axial Cap Screw Ø1.6 Cannula 8.5x60mm, 5.5mm Rod, Long Reduction Type
• 08800048496184: Hole Poly-Axial Cap Screw Ø1.6 Cannula 8.5x55mm, 5.5mm Rod, Long Reduction Type
• 08800048496177: Hole Poly-Axial Cap Screw Ø1.6 Cannula 8.5x50mm, 5.5mm Rod, Long Reduction Type
• 08800048496160: Hole Poly-Axial Cap Screw Ø1.6 Cannula 8.5x45mm, 5.5mm Rod, Long Reduction Type
• 08800048496153: Hole Poly-Axial Cap Screw Ø1.6 Cannula 8.5x40mm, 5.5mm Rod, Long Reduction Type
• 08800048496146: Hole Poly-Axial Cap Screw Ø1.6 Cannula 8.5x35mm, 5.5mm Rod, Long Reduction Type
• 08800048496139: Hole Poly-Axial Cap Screw Ø1.6 Cannula 8.5x30mm, 5.5mm Rod, Long Reduction Type
• 08800048496122: Hole Poly-Axial Cap Screw Ø1.6 Cannula 8.0x60mm, 5.5mm Rod, Long Reduction Type
• 08800048496115: Hole Poly-Axial Cap Screw Ø1.6 Cannula 8.0x55mm, 5.5mm Rod, Long Reduction Type
• 08800048496108: Hole Poly-Axial Cap Screw Ø1.6 Cannula 8.0x50mm, 5.5mm Rod, Long Reduction Type
• 08800048496092: Hole Poly-Axial Cap Screw Ø1.6 Cannula 8.0x45mm, 5.5mm Rod, Long Reduction Type
• 08800048496085: Hole Poly-Axial Cap Screw Ø1.6 Cannula 8.0x40mm, 5.5mm Rod, Long Reduction Type
• 08800048496078: Hole Poly-Axial Cap Screw Ø1.6 Cannula 8.0x35mm, 5.5mm Rod, Long Reduction Type
• 08800048496061: Hole Poly-Axial Cap Screw Ø1.6 Cannula 8.0x30mm, 5.5mm Rod, Long Reduction Type
• 08800048496054: Hole Poly-Axial Cap Screw Ø1.6 Cannula 6.0x25mm, 5.5mm Rod, Long Reduction Type
• 08800048496047: Hole Poly-Axial Cap Screw Ø2.5 Cannula 8.5x60mm, 5.5mm Rod, Long Reduction Type
• 08800048496030: Hole Poly-Axial Cap Screw Ø2.5 Cannula 8.0x60mm, 5.5mm Rod, Long Reduction Type
• 08800048496023: Hole Poly-Axial Cap Screw Ø2.5 Cannula 8.0x55mm, 5.5mm Rod, Long Reduction Type
• 08800048496016: Hole Poly-Axial Cap Screw Ø2.5 Cannula 8.0x50mm, 5.5mm Rod, Long Reduction Type
• 08800048496009: Hole Poly-Axial Cap Screw Ø2.5 Cannula 8.0x45mm, 5.5mm Rod, Long Reduction Type
• 08800048495996: Hole Poly-Axial Cap Screw Ø2.5 Cannula 8.0x40mm, 5.5mm Rod, Long Reduction Type
• 08800048495989: Hole Poly-Axial Cap Screw Ø2.5 Cannula 8.0x35mm, 5.5mm Rod, Long Reduction Type