510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K950395Substantially Equivalent for Some Indications

Thermocool System

Zimmer GmbH, Dover OH / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K950395 is the FDA 510(k) clearance record for THERMOCOOL SYSTEM, a class II device, cleared for Zimmer, Inc. on under FDA product code ILO (Pack, Hot Or Cold, Water Circulating). FDA records list 872 510(k) clearances for Zimmer, Inc., from to . As of , FDA records show no recalls naming K950395.

Clearance record

Decision date
Received
(198 days to decision)
Product code
ILO Pack, Hot Or Cold, Water Circulating
Regulation
21 CFR 890.5720
Device class
Class II
Review panel
Physical Medicine
Applicant
Zimmer, Inc. 200 W. Ohio Ave., Dover OH
Third party review
No

Clearances, product code ILO

Trailing 12 months

FDA records hold no clearances under product code ILO in the trailing twelve months.

FDA records show no clearances under product code ILO in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ILO, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260