510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K162929Substantially Equivalent

Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker

Stryker Corp., Freiburg Baden-Wurttemberg, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162929 is the FDA 510(k) clearance record for Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker, a class II device, cleared for Stryker Corporation on under FDA product code HAW (Neurological Stereotaxic Instrument). FDA records list 568 510(k) clearances for Stryker Corporation, from to . As of , FDA records show no recalls naming K162929.

Clearance record

Decision date
Received
(126 days to decision)
Product code
HAW Neurological Stereotaxic Instrument
Regulation
21 CFR 882.4560
Device class
Class II
Review panel
Neurology
Applicant
Stryker Corporation Botzinger Strasse 41, Freiburg Baden-Wurttemberg, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HAW

Trailing 12 months
4 clearances under product code HAW in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HAW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20260
July 20260
August 20261
September 20261
October 20260