Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Waypoint GPS

K-Number: K222106 · 2023-05-12

Decision Date2023-05-12
Product CodeQWP
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Waypoint GPS is a medical device manufactured by Waypoint Orthopedics, Inc.. It received FDA 510(k) clearance on 2023-05-12 under approval number K222106. The device is classified under product code QWP. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Waypoint GPS?

Waypoint GPS is a medical device that received FDA 510(k) clearance on 2023-05-12. It is manufactured by Waypoint Orthopedics, Inc.. The 510(k) number is K222106.

When was Waypoint GPS approved by the FDA?

Waypoint GPS received FDA 510(k) clearance on 2023-05-12, under approval number K222106.

What company makes Waypoint GPS?

Waypoint GPS is manufactured by Waypoint Orthopedics, Inc..

What is the FDA product code for Waypoint GPS?

The FDA product code for Waypoint GPS is QWP.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.