510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
DEN210058Unknown

ELEOSx™ Limb Salvage System

Onkos Surgical, Inc., Parsippany NJ / Direct, Unknown
FDA source (opens on fda.gov)

DEN210058 is the FDA 510(k) clearance record for ELEOSx™ Limb Salvage System, a class II device, cleared for Onkos Surgical on under FDA product code QZZ (Limb And Joint Salvage Device With Coating For Bacteria Reduction). FDA's definition for product code QZZ reads: "A limb and joint salvage device with quaternary ammonium compound coating is a metallic implant with or without polymer bearing for bone and joint replacement. Implants are for resection and replacement of an extremity bone (including the...". FDA records list 11 510(k) clearances for Onkos Surgical, from to . As of , FDA records show no recalls naming DEN210058.

Clearance record

Decision date
Received
(827 days to decision)
Product code
QZZ Limb And Joint Salvage Device With Coating For Bacteria Reduction
Regulation
21 CFR 888.3900
Device class
Class II
Review panel
Orthopedic
Applicant
Onkos Surgical 77 E. Halsey Rd., Parsippany NJ
Third party review
No

Clearances, product code QZZ

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