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
K903247Substantially Equivalent

Adjustable Angle Guide

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

K903247 is the FDA 510(k) clearance record for ADJUSTABLE ANGLE GUIDE, a class I device, cleared for Onyx Medical Corp. on under FDA product code LXH (Orthopedic Manual Surgical Instrument). FDA records list 48 510(k) clearances for Onyx Medical Corp., from to . As of , FDA records show no recalls naming K903247.

Clearance record

Decision date
Received
(6 days to decision)
Product code
LXH Orthopedic Manual Surgical Instrument
Regulation
21 CFR 888.4540
Device class
Class I
Review panel
Orthopedic
Applicant
Onyx Medical Corp. 152 Collins St., Memphis TN
Third party review
No

Clearances, product code LXH

Trailing 12 months

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

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