510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K895378Substantially Equivalent

Proximal Cement Spacer

Osteonics Reconstructive Products Div., Allendale NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895378 is the FDA 510(k) clearance record for PROXIMAL CEMENT SPACER, a class II device, cleared for Osteonics Reconstructive Products Div. on under FDA product code JDK (Prosthesis, Hip, Cement Restrictor). FDA records list 2 510(k) clearances for Osteonics Reconstructive Products Div., from to . As of , FDA records show no recalls naming K895378.

Clearance record

Decision date
Received
(84 days to decision)
Product code
JDK Prosthesis, Hip, Cement Restrictor
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Osteonics Reconstructive Products Div. 59 Rte. 17, Allendale NJ
Third party review
No

Clearances, product code JDK

Trailing 12 months

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

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