510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K803165Substantially Equivalent

Acetabular Cement Compressor

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

K803165 is the FDA 510(k) clearance record for ACETABULAR CEMENT COMPRESSOR, a class I device, cleared for Zimmer, Inc. on under FDA product code HXO (Pusher, Socket). FDA records list 872 510(k) clearances for Zimmer, Inc., from to . As of , FDA records show no recalls naming K803165.

Clearance record

Decision date
Received
(16 days to decision)
Product code
HXO Pusher, Socket
Regulation
21 CFR 888.4540
Device class
Class I
Review panel
Orthopedic
Applicant
Zimmer, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HXO

Trailing 12 months

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

FDA records show no clearances under product code HXO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HXO, 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