IMPLANET SPINE SYSTEM 350231

GUDID 03607503502313

Offset Rod to Rod Connector

IMPLANET

Trans-facet-screw internal spinal fixation system, sterile

• Primary Device ID: 03607503502313
• NIH Device Record Key: 106e0211-adc4-4615-8795-3666b0101857
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMPLANET SPINE SYSTEM
• Version Model Number: Offset Rod to Rod Connector
• Catalog Number: 350231
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Outer Diameter: 6 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03607503502313 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143731

FDA Product Code

• OSH: Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-06-04
• Device Publish Date: 2015-09-23

On-Brand Devices [IMPLANET SPINE SYSTEM]

• 03607503502429: Axial Rod to Rod Connector
• 03607503502412: Axial Rod to Rod Connector
• 03607503502405: Offset Rod to Rod Connector
• 03607503502399: Offset Rod to Rod Connector
• 03607503502382: Offset Rod to Rod Connector
• 03607503502375: Offset Rod to Rod Connector
• 03607503502368: Offset Rod to Rod Connector
• 03607503502351: Offset Rod to Rod Connector
• 03607503502344: Offset Rod to Rod Connector
• 03607503502337: Offset Rod to Rod Connector
• 03607503502320: Offset Rod to Rod Connector
• 03607503502313: Offset Rod to Rod Connector
• 03607505503110: Sterilization Instruments Container - USA Tray 1
• 03607505502823: Sterilization Instruments Container - Tray 3 Defor
• 03607505502809: Implanet Spine System Container
• 03607505502793: Sterilization Instruments Container - Lid 2
• 03607505502762: Sterilization Instruments Container -Tray 2
• 03607505502755: Sterilization Instruments Container -Tray 1
• 03607505502748: Sterilization Instruments Container - Base 2
• 03607505502731: Sterilization Instruments Container - Base 1