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
K242091Substantially Equivalent

Bolo Button System

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

K242091 is the FDA 510(k) clearance record for Bolo Button System, a class II device, cleared for Fusion Orthopedics on under FDA product code HTN (Washer, Bolt Nut). FDA records list 13 510(k) clearances for Fusion Orthopedics, from to . As of , FDA records show no recalls naming K242091.

Clearance record

Decision date
Received
(159 days to decision)
Product code
HTN Washer, Bolt Nut
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Fusion Orthopedics 6859 E Rembrandt Ave. Suite 122, Mesa AZ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HTN

Trailing 12 months
3 clearances under product code HTN in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HTN, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20261
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260