510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K903264Substantially Equivalent

K-Wire

Onyx Medical LLC, Memphis TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903264 is the FDA 510(k) clearance record for K-WIRE, a class II device, cleared for Onyx Medical Corp. on under FDA product code HTY (Pin, Fixation, Smooth). FDA records list 48 510(k) clearances for Onyx Medical Corp., from to . As of , FDA records show no recalls naming K903264.

Clearance record

Decision date
Received
(6 days to decision)
Product code
HTY Pin, Fixation, Smooth
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Onyx Medical Corp. 152 Collins St., Memphis TN
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