510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K961120Substantially Equivalent

Marker System for Stereotaxic Navigation

Howmedica Leibinger, Inc., Dallas TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K961120 is the FDA 510(k) clearance record for MARKER SYSTEM FOR STEREOTAXIC NAVIGATION, a class II device, cleared for Howmedica Leibinger, Inc. on under FDA product code HAW (Neurological Stereotaxic Instrument). FDA records list 11 510(k) clearances for Howmedica Leibinger, Inc., from to . As of , FDA records show no recalls naming K961120.

Clearance record

Decision date
Received
(50 days to decision)
Product code
HAW Neurological Stereotaxic Instrument
Regulation
21 CFR 882.4560
Device class
Class II
Review panel
Neurology
Applicant
Howmedica Leibinger, Inc. 14540 Beltwood Pkwy. E., Dallas TX
510(k) summary
Summary
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