Cleared Traditional

K955540 - HAND HELD ATLAS INSTRUMENT

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.

FDA 510(k) Submission Details - K955540

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 116d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

LXM Device Classification - Class 0,

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

Regulatory Peers - LXM Manipulator, Plunger-like Joint

All 30
Devices cleared under the same product code (LXM) and FDA review panel - the closest regulatory comparables to K955540.
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K946258 · Spinalight, Inc. · Nov 1995
NEW-STIM SPINAL ADJUSTMENT INSTRUMENT
K944369 · Lawrence E. Newsum, DC · Apr 1995
K955540 · HAND HELD ATLAS INSTRUMENT
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