510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K222106Substantially Equivalent

Waypoint GPS

Waypoint Orthopedics, Malvern PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K222106 is the FDA 510(k) clearance record for Waypoint GPS, a class II device, cleared for Waypoint Orthopedics, Inc. on under FDA product code QWP (Optical Neurosurgical Nerve Locator). FDA's definition for product code QWP reads: "To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery". FDA records list one 510(k) clearance for Waypoint Orthopedics, Inc. As of , FDA records show no recalls naming K222106.

Clearance record

Decision date
Received
(298 days to decision)
Product code
QWP Optical Neurosurgical Nerve Locator
Regulation
21 CFR 874.1820
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Waypoint Orthopedics, Inc. 300 Applebrooke Dr., Malvern PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QWP

Trailing 12 months

FDA records hold no clearances under product code QWP in the trailing twelve months.

FDA records show no clearances under product code QWP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QWP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260