510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K894708Substantially Equivalent

Pt Distal Tip Cement Spacer

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

K894708 is the FDA 510(k) clearance record for PT DISTAL TIP CEMENT SPACER, a class II device, cleared for Osteonics Corp. on under FDA product code JDK (Prosthesis, Hip, Cement Restrictor). FDA records list 178 510(k) clearances for Osteonics Corp., from to . As of , FDA records show no recalls naming K894708.

Clearance record

Decision date
Received
(78 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 Corp. 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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JDK, 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