Cleared Traditional

K822885 - HALO TRACTION CERVICAL IMMOBILIZATION

K822885 is an FDA 510(k) clearance for HALO TRACTION CERVICAL IMMOBILIZATION, manufactured by Orthopedic Systems, Inc.. The device is a Class 2 Neurology device with product code HAX cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K822885 · Orthopedic Systems, Inc. · Neurology device
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Nov 1982
Decision
55d
Days
Class 2
Risk

K822885 is an FDA 510(k) clearance for the HALO TRACTION CERVICAL IMMOBILIZATION. Classified as Tong, Skull For Traction (product code HAX), Class II - Special Controls.

Submitted by Orthopedic Systems, Inc. (Walker, US). The FDA issued a Cleared decision on November 22, 1982 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5960 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Orthopedic Systems, Inc. devices

FDA 510(k) Submission Details - K822885

510(k) Number K822885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1982
Decision Date November 22, 1982
Days to Decision 55 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 148d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HAX Device Classification - Class 2, Special Controls

Product Code HAX Tong, Skull For Traction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5960
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.