510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K770890Substantially Equivalent

Splint, Cockup

Mizuho Orthopedic Systems Inc, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K770890 is the FDA 510(k) clearance record for SPLINT, COCKUP, a class I device, cleared for Orthopedic Systems, Inc. on under FDA product code IQM (Splint, Temporary Training). FDA records list 95 510(k) clearances for MIZUHO ORTHOPEDIC SYSTEMS, INC., from to . As of , FDA records show no recalls naming K770890.

Clearance record

Decision date
Received
(10 days to decision)
Product code
IQM Splint, Temporary Training
Regulation
21 CFR 890.3025
Device class
Class I
Review panel
Physical Medicine
Applicant
Orthopedic Systems, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IQM

Trailing 12 months

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

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