Hedjet System

GUDID 08809974004333

Hedjet 20mm Reduction Poly axial Screw 10.0x80mm, Ø5.5mm Rod

Medyssey Co., Ltd.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 08809974004333
• NIH Device Record Key: 85c7e35f-abfb-4e12-9342-ec69dcc3a11b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hedjet System
• Version Model Number: 20DZRPS10080
• 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	08809974004333 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232218

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[08809974004333]

Moist Heat or Steam Sterilization

[08809974004333]

Moist Heat or Steam Sterilization

[08809974004333]

Moist Heat or Steam Sterilization

[08809974004333]

Moist Heat or Steam Sterilization

[08809974004333]

Moist Heat or Steam Sterilization

[08809974004333]

Moist Heat or Steam Sterilization

[08809974004333]

Moist Heat or Steam Sterilization

[08809974004333]

Moist Heat or Steam Sterilization

[08809974004333]

Moist Heat or Steam Sterilization

[08809974004333]

Moist Heat or Steam Sterilization

[08809974004333]

Moist Heat or Steam Sterilization

[08809974004333]

Moist Heat or Steam Sterilization

[08809974004333]

Moist Heat or Steam Sterilization

[08809974004333]

Moist Heat or Steam Sterilization

[08809974004333]

Moist Heat or Steam Sterilization

[08809974004333]

Moist Heat or Steam Sterilization

[08809974004333]

Moist Heat or Steam Sterilization

[08809974004333]

Moist Heat or Steam Sterilization

[08809974004333]

Moist Heat or Steam Sterilization

[08809974004333]

Moist Heat or Steam Sterilization

[08809974004333]

Moist Heat or Steam Sterilization

[08809974004333]

Moist Heat or Steam Sterilization

[08809974004333]

Moist Heat or Steam Sterilization

[08809974004333]

Moist Heat or Steam Sterilization

[08809974004333]

Moist Heat or Steam Sterilization

[08809974004333]

Moist Heat or Steam Sterilization

[08809974004333]

Moist Heat or Steam Sterilization

[08809974004333]

Moist Heat or Steam Sterilization

[08809974004333]

Moist Heat or Steam Sterilization

[08809974004333]

Moist Heat or Steam Sterilization

[08809974004333]

Moist Heat or Steam Sterilization

[08809974004333]

Moist Heat or Steam Sterilization

[08809974004333]

Moist Heat or Steam Sterilization

[08809974004333]

Moist Heat or Steam Sterilization

[08809974004333]

Moist Heat or Steam Sterilization

[08809974004333]

Moist Heat or Steam Sterilization

[08809974004333]

Moist Heat or Steam Sterilization

[08809974004333]

Moist Heat or Steam Sterilization

[08809974004333]

Moist Heat or Steam Sterilization

[08809974004333]

Moist Heat or Steam Sterilization

[08809974004333]

Moist Heat or Steam Sterilization

[08809974004333]

Moist Heat or Steam Sterilization

[08809974004333]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-27
• Device Publish Date: 2023-09-19

On-Brand Devices [Hedjet System]

• 08800048443089: Hedjet Poly axial Pedicle Screw 4.0x20mm, Ø5.5mm Rod
• 08800048445366: Hedjet Poly axial Pedicle Screw 10.0x120mm, Ø5.5mm Rod
• 08800048445359: Hedjet Poly axial Pedicle Screw 10.0x115mm, Ø5.5mm Rod
• 08800048445342: Hedjet Poly axial Pedicle Screw 10.0x110mm, Ø5.5mm Rod
• 08800048445335: Hedjet Poly axial Pedicle Screw 10.0x105mm, Ø5.5mm Rod
• 08800048445328: Hedjet Poly axial Pedicle Screw 10.0x100mm, Ø5.5mm Rod
• 08800048445311: Hedjet Poly axial Pedicle Screw 10.0x95mm, Ø5.5mm Rod
• 08800048445304: Hedjet Poly axial Pedicle Screw 10.0x90mm, Ø5.5mm Rod
• 08800048445298: Hedjet Poly axial Pedicle Screw 10.0x85mm, Ø5.5mm Rod
• 08800048445281: Hedjet Poly axial Pedicle Screw 10.0x80mm, Ø5.5mm Rod
• 08800048445274: Hedjet Poly axial Pedicle Screw 10.0x75mm, Ø5.5mm Rod
• 08800048445267: Hedjet Poly axial Pedicle Screw 10.0x70mm, Ø5.5mm Rod
• 08800048445250: Hedjet Poly axial Pedicle Screw 10.0x65mm, Ø5.5mm Rod
• 08800048445243: Hedjet Poly axial Pedicle Screw 10.0x60mm, Ø5.5mm Rod
• 08800048445236: Hedjet Poly axial Pedicle Screw 10.0x55mm, Ø5.5mm Rod
• 08800048445229: Hedjet Poly axial Pedicle Screw 10.0x50mm, Ø5.5mm Rod
• 08800048445212: Hedjet Poly axial Pedicle Screw 10.0x45mm, Ø5.5mm Rod
• 08800048445205: Hedjet Poly axial Pedicle Screw 10.0x40mm, Ø5.5mm Rod
• 08800048445199: Hedjet Poly axial Pedicle Screw 10.0x35mm, Ø5.5mm Rod
• 08800048445182: Hedjet Poly axial Pedicle Screw 10.0x30mm, Ø5.5mm Rod
• 08800048445175: Hedjet Poly axial Pedicle Screw 9.5x120mm, Ø5.5mm Rod
• 08800048445168: Hedjet Poly axial Pedicle Screw 9.5x115mm, Ø5.5mm Rod
• 08800048445144: Hedjet Poly axial Pedicle Screw 9.5x105mm, Ø5.5mm Rod
• 08800048445137: Hedjet Poly axial Pedicle Screw 9.5x100mm, Ø5.5mm Rod
• 08800048445120: Hedjet Poly axial Pedicle Screw 9.5x95mm, Ø5.5mm Rod
• 08800048445113: Hedjet Poly axial Pedicle Screw 9.5x90mm, Ø5.5mm Rod
• 08800048445106: Hedjet Poly axial Pedicle Screw 9.5x85mm, Ø5.5mm Rod
• 08800048445090: Hedjet Poly axial Pedicle Screw 9.5x80mm, Ø5.5mm Rod
• 08800048445083: Hedjet Poly axial Pedicle Screw 9.5x75mm, Ø5.5mm Rod
• 08800048445076: Hedjet Poly axial Pedicle Screw 9.5x70mm, Ø5.5mm Rod
• 08800048445069: Hedjet Poly axial Pedicle Screw 9.5x65mm, Ø5.5mm Rod
• 08800048445052: Hedjet Poly axial Pedicle Screw 9.5x55mm, Ø5.5mm Rod
• 08800048445045: Hedjet Poly axial Pedicle Screw 9.5x55mm, Ø5.5mm Rod
• 08800048445038: Hedjet Poly axial Pedicle Screw 9.5x50mm, Ø5.5mm Rod
• 08800048445021: Hedjet Poly axial Pedicle Screw 9.5x45mm, Ø5.5mm Rod
• 08800048445014: Hedjet Poly axial Pedicle Screw 9.5x40mm, Ø5.5mm Rod
• 08800048445007: Hedjet Poly axial Pedicle Screw 9.5x35mm, Ø5.5mm Rod
• 08800048444994: Hedjet Poly axial Pedicle Screw 9.5x30mm, Ø5.5mm Rod
• 08800048444987: Hedjet Poly axial Pedicle Screw 9.0x120mm, Ø5.5mm Rod
• 08800048444970: Hedjet Poly axial Pedicle Screw 9.0x115mm, Ø5.5mm Rod
• 08800048444963: Hedjet Poly axial Pedicle Screw 9.0x110mm, Ø5.5mm Rod
• 08800048444956: Hedjet Poly axial Pedicle Screw 9.0x105mm, Ø5.5mm Rod
• 08800048444949: Hedjet Poly axial Pedicle Screw 9.0x100mm, Ø5.5mm Rod
• 08800048444932: Hedjet Poly axial Pedicle Screw 9.0x95mm, Ø5.5mm Rod
• 08800048444925: Hedjet Poly axial Pedicle Screw 9.0x90mm, Ø5.5mm Rod
• 08800048444918: Hedjet Poly axial Pedicle Screw 9.0x85mm, Ø5.5mm Rod
• 08800048444901: Hedjet Poly axial Pedicle Screw 9.0x80mm, Ø5.5mm Rod
• 08800048444895: Hedjet Poly axial Pedicle Screw 9.0x75mm, Ø5.5mm Rod
• 08800048444888: Hedjet Poly axial Pedicle Screw 9.0x70mm, Ø5.5mm Rod
• 08800048444871: Hedjet Poly axial Pedicle Screw 9.0x65mm, Ø5.5mm Rod