510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K861086Substantially Equivalent

Zimmer Vacuum Mixing System

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

K861086 is the FDA 510(k) clearance record for ZIMMER VACUUM MIXING SYSTEM, a class I device, cleared for Zimmer, Inc. on under FDA product code JDZ (Mixer, Cement, For Clinical Use). FDA records list 872 510(k) clearances for Zimmer, Inc., from to . As of , FDA records show no recalls naming K861086.

Clearance record

Decision date
Received
(24 days to decision)
Product code
JDZ Mixer, Cement, For Clinical Use
Regulation
21 CFR 888.4210
Device class
Class I
Review panel
Orthopedic
Applicant
Zimmer, Inc. P.O. Box 708, Warsaw IN
Third party review
No

Clearances, product code JDZ

Trailing 12 months

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

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