510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K100314Substantially Equivalent

Imns Medacta Navigation System,33.221000us

Medacta International SA, Camarillo CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100314 is the FDA 510(k) clearance record for IMNS MEDACTA NAVIGATION SYSTEM,33.221000US, a class II device, cleared for Medacta International S.A. on under FDA product code HAW (Neurological Stereotaxic Instrument). FDA records list 205 510(k) clearances for Medacta International S.A., from to . As of , FDA records show no recalls naming K100314.

Clearance record

Decision date
Received
(55 days to decision)
Product code
HAW Neurological Stereotaxic Instrument
Regulation
21 CFR 882.4560
Device class
Class II
Review panel
Neurology
Applicant
Medacta International S.A. 4725 Calle Quetzal Suite B, Camarillo CA
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