510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K934253Substantially Equivalent

Exactech All Poly Acetabular Cup

Exactech, Inc., Gainesville FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934253 is the FDA 510(k) clearance record for EXACTECH ALL POLY ACETABULAR CUP, a class I device, cleared for Exactech, Inc. on under FDA product code JDZ (Mixer, Cement, For Clinical Use). FDA records list 186 510(k) clearances for Exactech, Inc., from to . As of , FDA records show no recalls naming K934253.

Clearance record

Decision date
Received
(241 days to decision)
Product code
JDZ Mixer, Cement, For Clinical Use
Regulation
21 CFR 888.4210
Device class
Class I
Review panel
Orthopedic
Applicant
Exactech, Inc. 4613 NW 6th St., Suite D, Gainesville FL
510(k) summary
Summary
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