510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K810557Substantially Equivalent

Hip Abduction Splint

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

K810557 is the FDA 510(k) clearance record for HIP ABDUCTION SPLINT, a class I device, cleared for Orthomedics on under FDA product code IOZ (Splint, Abduction, Congenital Hip Dislocation). FDA records list 16 510(k) clearances for Orthomedics, from to . As of , FDA records show no recalls naming K810557.

Clearance record

Decision date
Received
(11 days to decision)
Product code
IOZ Splint, Abduction, Congenital Hip Dislocation
Regulation
21 CFR 890.3665
Device class
Class I
Review panel
Physical Medicine
Applicant
Orthomedics 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IOZ

Trailing 12 months

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

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