510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K811312Substantially Equivalent

Myo-Metric II

Mycron Medical, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K811312 is the FDA 510(k) clearance record for MYO-METRIC II, a class II device, cleared for Mycron Medical, Inc. on under FDA product code LBB (Dynamometer, Ac-Powered). FDA records list one 510(k) clearance for Mycron Medical, Inc. As of , FDA records show no recalls naming K811312.

Clearance record

Decision date
Received
(29 days to decision)
Product code
LBB Dynamometer, Ac-Powered
Regulation
21 CFR 888.1240
Device class
Class II
Review panel
Orthopedic
Applicant
Mycron Medical, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LBB

Trailing 12 months

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

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