Cleared Traditional

K955084 - ASPACH 65,000 (MODIFICATION) (FDA 510(k) Clearance)

Class I Orthopedic device.

K955084 · The Anspach Effort, Inc. · Orthopedic device
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Jan 1996
Decision
90d
Days
Class 1
Risk

K955084 is an FDA 510(k) clearance for the ASPACH 65,000 (MODIFICATION). Classified as Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment (product code HSZ), Class I - General Controls.

Submitted by The Anspach Effort, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on January 17, 1996 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.4820 - 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 The Anspach Effort, Inc. devices

Submission Details

510(k) Number K955084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1995
Decision Date January 17, 1996
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.