Guided Pedicle System (GPS)

GUDID 00196852379552

Single use, disposable device and a software application that is downloaded onto the provided tablet. The system is intended to provide feedback to surgeons during pilot hole drilling for pedicle screw placement.

Waypoint Orthopedics, Inc.

Pedicle screw guide

• Primary Device ID: 00196852379552
• NIH Device Record Key: bb5b4ea2-9994-4fbc-be10-e49f76acde8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guided Pedicle System (GPS)
• Version Model Number: W101
• Company DUNS: 144837124
• Company Name: Waypoint Orthopedics, Inc.
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00196852379552 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222106

FDA Product Code

• QWP: Optical Neurosurgical Nerve Locator

Sterilization

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

[00196852379552]

Ethylene Oxide

[00196852379552]

Ethylene Oxide

[00196852379552]

Ethylene Oxide

[00196852379552]

Ethylene Oxide

[00196852379552]

Ethylene Oxide

[00196852379552]

Ethylene Oxide

[00196852379552]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-26
• Device Publish Date: 2026-01-16