Cleared Traditional

K955084 - ASPACH 65

K955084 is an FDA 510(k) clearance for ASPACH 65, manufactured by The Anspach Effort, Inc.. The device is a Class 1 Orthopedic device with product code HSZ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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

FDA 510(k) Submission Details - K955084

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

HSZ Device Classification - Class 1, General Controls

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.

Regulatory Peers - HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment

All 31
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