510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K802460Substantially Equivalent

Helfet Elbow Prosthesis

Depuy, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K802460 is the FDA 510(k) clearance record for HELFET ELBOW PROSTHESIS, a class II device, cleared for Depuy, Inc. on under FDA product code JDB (Prosthesis, Elbow, Semi-Constrained, Cemented). FDA records list 14 510(k) clearances for Depuy, Inc., from to . As of , FDA records show no recalls naming K802460.

Clearance record

Decision date
Received
(42 days to decision)
Product code
JDB Prosthesis, Elbow, Semi-Constrained, Cemented
Regulation
21 CFR 888.3160
Device class
Class II
Review panel
Orthopedic
Applicant
Depuy, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code JDB

Trailing 12 months

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

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