Alphatec Navigation Instrument

GUDID 00190376003689

Cannulated Reduction Polyaxial Screw Driver, NI

ALPHATEC SPINE, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00190376003689
• NIH Device Record Key: b69e85a2-13c9-4d37-b0ed-bc56a4b5dc37
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alphatec Navigation Instrument
• Version Model Number: 87781
• Company DUNS: 602465783
• Company Name: ALPHATEC SPINE, INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	00190376003689 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153603

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

[00190376003689]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-14

On-Brand Devices [Alphatec Navigation Instrument]

• 00190376018737: 4.3 mm Tap, NI
• 00190376003689: Cannulated Reduction Polyaxial Screw Driver, NI
• 00190376003337: Cannulated Polyaxial Screw Driver, NI