510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821256Substantially Equivalent

Counter-Rotation System

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

K821256 is the FDA 510(k) clearance record for COUNTER-ROTATION SYSTEM, a class I device, cleared for The Langer Group on under FDA product code ITN (Splint, Denis Brown). FDA records list 2 510(k) clearances for The Langer Group, from to . As of , FDA records show no recalls naming K821256.

Clearance record

Decision date
Received
(54 days to decision)
Product code
ITN Splint, Denis Brown
Regulation
21 CFR 890.3675
Device class
Class I
Review panel
Physical Medicine
Applicant
The Langer Group 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code ITN

Trailing 12 months

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

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