Cleared Traditional

K172536 - Atlas Percussion Adjusting Instrument (FDA 510(k) Clearance)

K172536 · Spinalight, Inc. · Physical Medicine device
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Jun 2018
Decision
302d
Days
-
Risk

K172536 is an FDA 510(k) clearance for the Atlas Percussion Adjusting Instrument. Classified as Manipulator, Plunger-like Joint (product code LXM).

Submitted by Spinalight, Inc. (St. Petersburg, US). The FDA issued a Cleared decision on June 20, 2018 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K172536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2017
Decision Date June 20, 2018
Days to Decision 302 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
187d slower than avg
Panel avg: 115d · This submission: 302d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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