510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K822885Substantially Equivalent

Halo Traction Cervical Immobilization

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

K822885 is the FDA 510(k) clearance record for HALO TRACTION CERVICAL IMMOBILIZATION, a class II device, cleared for Orthopedic Systems, Inc. on under FDA product code HAX (Tong, Skull For Traction). FDA records list 95 510(k) clearances for MIZUHO ORTHOPEDIC SYSTEMS, INC., from to . As of , FDA records show no recalls naming K822885.

Clearance record

Decision date
Received
(55 days to decision)
Product code
HAX Tong, Skull For Traction
Regulation
21 CFR 882.5960
Device class
Class II
Review panel
Neurology
Applicant
Orthopedic Systems, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code HAX

Trailing 12 months

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

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