Cleared Traditional

K954069 - ACE CERVICAL TRACTION HALOZS

K954069 is an FDA 510(k) clearance for ACE CERVICAL TRACTION HALOZS, manufactured by Ace Medical Co.. The device is a Class 2 Orthopedic device with product code HAX cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K954069 · Ace Medical Co. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
43d
Days
Class 2
Risk

K954069 is an FDA 510(k) clearance for the ACE CERVICAL TRACTION HALOZS, TONGS & PINS. Classified as Tong, Skull For Traction (product code HAX), Class II - Special Controls.

Submitted by Ace Medical Co. (El Segundo, US). The FDA issued a Cleared decision on October 12, 1995 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 882.5960 - the FDA orthopedic device regulatory 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 Ace Medical Co. devices

FDA 510(k) Submission Details - K954069

510(k) Number K954069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1995
Decision Date October 12, 1995
Days to Decision 43 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 122d · This submission: 43d
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 Orthopedic devices follow this clearance model.

Regulatory Peers - HAX Tong, Skull For Traction

Devices cleared under the same product code (HAX) and FDA review panel - the closest regulatory comparables to K954069.
PMT HALO SYSTEM
K090733 · Pmt Corp. · Jul 2009
NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE
K915530 · American Threshold Industries, Inc. · Aug 1992
MAYFIELD DISPOSABLE SKULL PINS
K853066 · Codman & Shurtleff, Inc. · Aug 1985
ACE UNIVERSAL TONG
K842680 · Buckman Co., Inc. · Sep 1984
HALO TRACTION CERVICAL IMMOBILIZATION
K822885 · Orthopedic Systems, Inc. · Nov 1982
HALO SUPPORT JACKET & ASSOC. HARDWARE
K792586 · Depuy, Inc. · Dec 1979