510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K190136Substantially Equivalent

Fusion Silastic System

Fusion Orthopedics, LLC, Mesa AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K190136 is the FDA 510(k) clearance record for Fusion Silastic System, a class II device, cleared for Fusion Orthopedics, LLC on under FDA product code KWH (Prosthesis, Toe, Constrained, Polymer). FDA records list 13 510(k) clearances for Fusion Orthopedics, LLC, from to . As of , FDA records show no recalls naming K190136.

Clearance record

Decision date
Received
(265 days to decision)
Product code
KWH Prosthesis, Toe, Constrained, Polymer
Regulation
21 CFR 888.3720
Device class
Class II
Review panel
Orthopedic
Applicant
Fusion Orthopedics, LLC 4135 S. Power Rd., Mesa AZ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KWH

Trailing 12 months

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

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