Iliad Spinal System

GUDID 08809547363386

Cannulated Poly-Axial Screw 5.0mm x 35mm, 6.35mm Rod

Medyssey Co., Ltd.

Bone-screw internal spinal fixation system, non-sterile

Primary Device ID	08809547363386
NIH Device Record Key	5bf1ebde-742e-4c6c-9b0e-fbeb2e2d6d9c
Commercial Distribution Status	In Commercial Distribution
Brand Name	Iliad Spinal System
Version Model Number	LCP5035
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	08809547363386 [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

[08809547363386]

Moist Heat or Steam Sterilization

[08809547363386]

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[08809547363386]

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[08809547363386]

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[08809547363386]

Moist Heat or Steam Sterilization

[08809547363386]

Moist Heat or Steam Sterilization

[08809547363386]

Moist Heat or Steam Sterilization

[08809547363386]

Moist Heat or Steam Sterilization

[08809547363386]

Moist Heat or Steam Sterilization

[08809547363386]

Moist Heat or Steam Sterilization

[08809547363386]

Moist Heat or Steam Sterilization

[08809547363386]

Moist Heat or Steam Sterilization

[08809547363386]

Moist Heat or Steam Sterilization

[08809547363386]

Moist Heat or Steam Sterilization

[08809547363386]

Moist Heat or Steam Sterilization

[08809547363386]

Moist Heat or Steam Sterilization

[08809547363386]

Moist Heat or Steam Sterilization

[08809547363386]

Moist Heat or Steam Sterilization

[08809547363386]

Moist Heat or Steam Sterilization

[08809547363386]

Moist Heat or Steam Sterilization

[08809547363386]

Moist Heat or Steam Sterilization

[08809547363386]

Moist Heat or Steam Sterilization

[08809547363386]

Moist Heat or Steam Sterilization

[08809547363386]

Moist Heat or Steam Sterilization

[08809547363386]

Moist Heat or Steam Sterilization

[08809547363386]

Moist Heat or Steam Sterilization

[08809547363386]

Moist Heat or Steam Sterilization

[08809547363386]

Moist Heat or Steam Sterilization

[08809547363386]

Moist Heat or Steam Sterilization

[08809547363386]

Moist Heat or Steam Sterilization

[08809547363386]

Moist Heat or Steam Sterilization

[08809547363386]

Moist Heat or Steam Sterilization

[08809547363386]

Moist Heat or Steam Sterilization

[08809547363386]

Moist Heat or Steam Sterilization

[08809547363386]

Moist Heat or Steam Sterilization

[08809547363386]

Moist Heat or Steam Sterilization

[08809547363386]

Moist Heat or Steam Sterilization

[08809547363386]

Moist Heat or Steam Sterilization

[08809547363386]

Moist Heat or Steam Sterilization

[08809547363386]

Moist Heat or Steam Sterilization

[08809547363386]

Moist Heat or Steam Sterilization

[08809547363386]

Moist Heat or Steam Sterilization

[08809547363386]

Moist Heat or Steam Sterilization

[08809547363386]

Moist Heat or Steam Sterilization

[08809547363386]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2024-08-08
Device Publish Date	2017-09-01

On-Brand Devices [Iliad Spinal System]

08800048446806	Polyaxial Pedicle Screw, Ø8.0mm X 40mm, Ø6.35mm (1/4-inch) Rod
08800048446790	Polyaxial Pedicle Screw, Ø7.5mm X 95mm, Ø6.35mm (1/4-inch) Rod
08800048446783	Polyaxial Pedicle Screw, Ø7.5mm X 85mm, Ø6.35mm (1/4-inch) Rod
08800048446776	Polyaxial Pedicle Screw, Ø7.5mm X 75mm, Ø6.35mm (1/4-inch) Rod
08800048401621	Polyaxial Pedicle Screw, Ø5.0mm X 45mm , Ø6.0mm Rod
08800048401614	Polyaxial Pedicle Screw, Ø5.0mm X 40mm , Ø6.0mm Rod
08800048401607	Polyaxial Pedicle Screw, Ø5.0mm X 35mm , Ø6.0mm Rod
08800048401591	Polyaxial Pedicle Screw, Ø5.0mm X 30mm , Ø6.0mm Rod
08800048401584	Polyaxial Pedicle Screw, Ø5.0mm X 25mm , Ø6.0mm Rod
08800048401577	Polyaxial Pedicle Screw, Ø5.0mm X 20mm , Ø6.0mm Rod
08800048401546	Polyaxial Pedicle Screw, Ø4.5mm X 45mm , Ø6.0mm Rod
08800048401539	Polyaxial Pedicle Screw, Ø4.5mm X 40mm , Ø6.0mm Rod
08800048401522	Polyaxial Pedicle Screw, Ø4.5mm X 35mm , Ø6.0mm Rod
08800048401515	Polyaxial Pedicle Screw, Ø4.5mm X 30mm , Ø6.0mm Rod
08800048401508	Polyaxial Pedicle Screw, Ø4.5mm X 25mm , Ø6.0mm Rod
08800048401492	Polyaxial Pedicle Screw, Ø4.5mm X 20mm , Ø6.0mm Rod
08800048401485	Polyaxial Pedicle Screw, Ø4.0mm X 40mm , Ø6.0mm Rod
08800048401478	Polyaxial Pedicle Screw, Ø4.0mm X 35mm , Ø6.0mm Rod
08800048401461	Polyaxial Pedicle Screw, Ø4.0mm X 30mm , Ø6.0mm Rod
08800048401454	Polyaxial Pedicle Screw, Ø4.0mm X 25mm , Ø6.0mm Rod
08800048401447	Polyaxial Pedicle Screw, Ø4.0mm X 20mm , Ø6.0mm Rod
08806364651269	Cannulated Poly-Axial Screw 8.5mm x 60mm, 6.35mm (1/4-inch) Rod, Reduction Type
08806364651252	Cannulated Poly-Axial Screw 8.5mm x 55mm, 6.35mm (1/4-inch) Rod, Reduction Type
08806364651245	Cannulated Poly-Axial Screw 8.5mm x 50mm, 6.35mm (1/4-inch) Rod, Reduction Type
08806364651238	Cannulated Poly-Axial Screw 8.5mm x 45mm, 6.35mm (1/4-inch) Rod, Reduction Type
08806364651221	Cannulated Poly-Axial Screw 8.5mm x 40mm, 6.35mm (1/4-inch) Rod, Reduction Type
08806364651214	Cannulated Poly-Axial Screw 8.5mm x 35mm, 6.35mm (1/4-inch) Rod, Reduction Type
08806364651207	Cannulated Poly-Axial Screw 8.5mm x 30mm, 6.35mm (1/4-inch) Rod, Reduction Type
08806364651191	Cannulated Poly-Axial Screw 8.0mm x 60mm, 6.35mm (1/4-inch) Rod, Reduction Type
08806364651184	Cannulated Poly-Axial Screw 8.0mm x 55mm, 6.35mm (1/4-inch) Rod, Reduction Type
08806364651177	Cannulated Poly-Axial Screw 8.0mm x 50mm, 6.35mm (1/4-inch) Rod, Reduction Type
08806364651160	Cannulated Poly-Axial Screw 8.0mm x 45mm, 6.35mm (1/4-inch) Rod, Reduction Type
08806364651153	Cannulated Poly-Axial Screw 8.0mm x 40mm, 6.35mm (1/4-inch) Rod, Reduction Type
08806364651146	Cannulated Poly-Axial Screw 8.0mm x 35mm, 6.35mm (1/4-inch) Rod, Reduction Type
08806364651139	Cannulated Poly-Axial Screw 8.0mm x 30mm, 6.35mm (1/4-inch) Rod, Reduction Type
08806364651122	Cannulated Poly-Axial Screw 7.5mm x 60mm, 6.35mm (1/4-inch) Rod, Reduction Type
08806364651115	Cannulated Poly-Axial Screw 7.5mm x 55mm, 6.35mm (1/4-inch) Rod, Reduction Type
08806364651108	Cannulated Poly-Axial Screw 7.5mm x 50mm, 6.35mm (1/4-inch) Rod, Reduction Type
08806364651092	Cannulated Poly-Axial Screw 7.5mm x 45mm, 6.35mm (1/4-inch) Rod, Reduction Type
08806364651085	Cannulated Poly-Axial Screw 7.5mm x 40mm, 6.35mm (1/4-inch) Rod, Reduction Type
08806364651078	Cannulated Poly-Axial Screw 7.5mm x 35mm, 6.35mm (1/4-inch) Rod, Reduction Type
08806364651061	Cannulated Poly-Axial Screw 7.5mm x 30mm, 6.35mm (1/4-inch) Rod, Reduction Type
08806364651054	Cannulated Poly-Axial Screw 7.0mm x 60mm, 6.35mm (1/4-inch) Rod, Reduction Type
08806364651047	Cannulated Poly-Axial Screw 7.0mm x 55mm, 6.35mm (1/4-inch) Rod, Reduction Type
08806364651030	Cannulated Poly-Axial Screw 7.0mm x 50mm, 6.35mm (1/4-inch) Rod, Reduction Type
08806364651023	Cannulated Poly-Axial Screw 7.0mm x 45mm, 6.35mm (1/4-inch) Rod, Reduction Type
08806364651016	Cannulated Poly-Axial Screw 7.0mm x 40mm, 6.35mm (1/4-inch) Rod, Reduction Type
08806364651009	Cannulated Poly-Axial Screw 7.0mm x 35mm, 6.35mm (1/4-inch) Rod, Reduction Type
08806364650996	Cannulated Poly-Axial Screw 7.0mm x 30mm, 6.35mm (1/4-inch) Rod, Reduction Type
08806364606504	Reduction Monoaxial Pedicle Screw, Ø8.5mm X 60mm, Ø6.35mm (1/4-inch) Rod

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