510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K203588Substantially Equivalent

ELEOS™ Limb Salvage System

Onkos Surgical, Inc., Parsippany NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K203588 is the FDA 510(k) clearance record for ELEOS™ Limb Salvage System, a class II device, cleared for Onkos Surgical on under FDA product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented). FDA records list 11 510(k) clearances for Onkos Surgical, from to . As of , FDA records show 3 recalls naming K203588.

Clearance record

Decision date
Received
(59 days to decision)
Product code
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Regulation
21 CFR 888.3350
Device class
Class II
Review panel
Orthopedic
Applicant
Onkos Surgical 77 E. Halsey Rd., Parsippany NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JDI

Trailing 12 months
3 clearances under product code JDI in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JDI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20261
August 20261
September 20260
October 20260