Jazz Spinal System

GUDID 03607506313435

Straight rod 5.5x120

IMPLANET

Bone-screw internal spinal fixation system rod

• Primary Device ID: 03607506313435
• NIH Device Record Key: 45df2ad1-d426-4ec0-8544-1c05fee20bc4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Jazz Spinal System
• Version Model Number: 631343
• Company DUNS: 291993439
• Company Name: IMPLANET
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03607506313435 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240392

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[03607506313435]

Moist Heat or Steam Sterilization

[03607506313435]

Moist Heat or Steam Sterilization

[03607506313435]

Moist Heat or Steam Sterilization

[03607506313435]

Moist Heat or Steam Sterilization

[03607506313435]

Moist Heat or Steam Sterilization

[03607506313435]

Moist Heat or Steam Sterilization

[03607506313435]

Moist Heat or Steam Sterilization

[03607506313435]

Moist Heat or Steam Sterilization

[03607506313435]

Moist Heat or Steam Sterilization

[03607506313435]

Moist Heat or Steam Sterilization

[03607506313435]

Moist Heat or Steam Sterilization

[03607506313435]

Moist Heat or Steam Sterilization

[03607506313435]

Moist Heat or Steam Sterilization

[03607506313435]

Moist Heat or Steam Sterilization

[03607506313435]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-07
• Device Publish Date: 2025-06-27

On-Brand Devices [Jazz Spinal System]

• 03607506353950: Cannulated Polyaxial Reduction Screw 7.5x50
• 03607506348284: Torsional Set Screw 5.5
• 03607506343777: Cannulated Polyaxial reduction screw 6.5x50
• 03607506343760: Cannulated Polyaxial reduction screw 6.5x45
• 03607506343753: Cannulated Polyaxial reduction screw 6.5x40
• 03607506343746: Cannulated Polyaxial reduction screw 6.5x35
• 03607506343654: Cannulated Polyaxial reduction screw 5.5x45
• 03607506343647: Cannulated Polyaxial reduction screw 5.5x40
• 03607506336144: Polyaxial Screw 7.5x50
• 03607506336137: Polyaxial Screw 7.5x45
• 03607506336120: Polyaxial Screw 7.5x40
• 03607506336038: Polyaxial Screw 6.5x50
• 03607506336021: Polyaxial Screw 6.5x45
• 03607506336014: Polyaxial Screw 6.5x40
• 03607506336007: Polyaxial Screw 6.5x35
• 03607506335994: Polyaxial Screw 6.5x30
• 03607506335925: Polyaxial Screw 5.5x45
• 03607506313442: Straight rod 5.5x130
• 03607506313435: Straight rod 5.5x120
• 03607506313428: Straight rod 5.5x110
• 03607506313411: Straight rod 5.5x100
• 03607506313398: Straight rod 5.5x90
• 03607506313374: Straight rod 5.5x80
• 03607506310526: Pre-Cut Rod 5.5x50
• 03607506310519: Pre-Cut Rod 5.5x45
• 03607506310502: Pre-Cut Rod 5.5x40