Cleared Traditional

K943819 - ISOLA ANTERIOR SYSTEM

K943819 is an FDA 510(k) clearance for ISOLA ANTERIOR SYSTEM, manufactured by Acromed Corp.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K943819 · Acromed Corp. · Orthopedic device
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Feb 1995
Decision
188d
Days
Class 2
Risk

K943819 is an FDA 510(k) clearance for the ISOLA ANTERIOR SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Acromed Corp. (Cleveland, US). The FDA issued a Cleared decision on February 9, 1995 after a review of 188 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Acromed Corp. devices

FDA 510(k) Submission Details - K943819

510(k) Number K943819 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 05, 1994
Decision Date February 09, 1995
Days to Decision 188 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 122d · This submission: 188d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWQ Device Classification - Class 2, Special Controls

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 470
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K943819.
AESCULAP CASPAR PLATE & SCREW SYSTEM FOR ANTERIOR CERVICAL FUSION
K953720 · Aesculap, Inc. · Nov 1995
UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM
K943725 · Synthes Spine · Aug 1995
SYNTHES (USA) ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM
K945700 · Synthes (Usa) · Jul 1995
EBI ANTERIOR CERVICAL SPINE SYSTEM
K943694 · Electro-Biology, Inc. · Feb 1995
ANTERIOR CERVIAL PLATING SYSTEM
K943523 · Smith & Nephew Richards, Inc. · Dec 1994
WEBB-MORLEY SPINE SYSTEM
K941367 · Electro-Biology, Inc. · Dec 1994