510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
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K073615Substantially Equivalent

Brainlab Knee Essential, Brainlab Knee Unlimited Ci Knee, Ci Knee Unlimited

Brainlab, Inc., Feldkirchen, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K073615 is the FDA 510(k) clearance record for BRAINLAB KNEE ESSENTIAL, BRAINLAB KNEE UNLIMITED CI KNEE, CI KNEE UNLIMITED, a class II device, cleared for Brainlab AG on under FDA product code HAW (Neurological Stereotaxic Instrument). FDA records list 146 510(k) clearances for Brainlab AG, from to . As of , FDA records show no recalls naming K073615.

Clearance record

Decision date
Received
(254 days to decision)
Product code
HAW Neurological Stereotaxic Instrument
Regulation
21 CFR 882.4560
Device class
Class II
Review panel
Neurology
Applicant
Brainlab AG Kapellenstrasse 12, Feldkirchen, DE
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