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Guided Pedicle System (GPS)

Waypoint Orthopedics, Inc. · Model W101 · UDI-DI 00196852379552

QWP Prescription
1
510(k) clearances
0
Adverse events
0
Recalls
1
Facilities

Description

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.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.