510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250315Substantially Equivalent

Ronavis – Fx (Fx-001)

Airs Inc., Daegu, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250315 is the FDA 510(k) clearance record for RONAVIS – FX (FX-001), a class II device, cleared for AIRS, Inc. on under FDA product code HTY (Pin, Fixation, Smooth). FDA records list one 510(k) clearance for AIRS, Inc. As of , FDA records show no recalls naming K250315.

Clearance record

Decision date
Received
(178 days to decision)
Product code
HTY Pin, Fixation, Smooth
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
AIRS, Inc. Robot Innovation Center Kiria 75, Nowon-Ru, Buk-Gu, Daegu, KR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HTY

Trailing 12 months
2 clearances under product code HTY 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 HTY, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260