510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K980502Substantially Equivalent

Osteonics Total Elbow System

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

K980502 is the FDA 510(k) clearance record for OSTEONICS TOTAL ELBOW SYSTEM, a class II device, cleared for Osteonics Corp. on under FDA product code JDC (Prosthesis, Elbow, Constrained, Cemented). FDA records list 178 510(k) clearances for Osteonics Corp., from to . As of , FDA records show no recalls naming K980502.

Clearance record

Decision date
Received
(85 days to decision)
Product code
JDC Prosthesis, Elbow, Constrained, Cemented
Regulation
21 CFR 888.3150
Device class
Class II
Review panel
Orthopedic
Applicant
Osteonics Corp. 59 Rte. 17, Allendale NJ
510(k) summary
Summary
Third party review
No

Clearances, product code JDC

Trailing 12 months

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

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