Cleared Traditional

K955540 - HAND HELD ATLAS INSTRUMENT (FDA 510(k) Clearance)

K955540 · Spinalight, Inc. · Physical Medicine device
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Mar 1996
Decision
90d
Days
-
Risk

K955540 is an FDA 510(k) clearance for the HAND HELD ATLAS INSTRUMENT. Classified as Manipulator, Plunger-like Joint (product code LXM).

Submitted by Spinalight, Inc. (Woodstock, US). The FDA issued a Cleared decision on March 4, 1996 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel. 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Spinalight, Inc. devices

Submission Details

510(k) Number K955540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1995
Decision Date March 04, 1996
Days to Decision 90 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LXM Manipulator, Plunger-like Joint
Device Class -