510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K031454Substantially Equivalent

Acumen Surgical Navigation System

Zimmer GmbH, Warsaw IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K031454 is the FDA 510(k) clearance record for ACUMEN SURGICAL NAVIGATION SYSTEM, a class II device, cleared for Biomet, Inc. on under FDA product code HAW (Neurological Stereotaxic Instrument). FDA records list 872 510(k) clearances for ZIMMER GMBH, from to . As of , FDA records show no recalls naming K031454.

Clearance record

Decision date
Received
(428 days to decision)
Product code
HAW Neurological Stereotaxic Instrument
Regulation
21 CFR 882.4560
Device class
Class II
Review panel
Neurology
Applicant
Biomet, Inc. 56 E. Bell Dr.,, Warsaw IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HAW

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