Cleared Traditional

K172536 - Atlas Percussion Adjusting Instrument

K172536 · Spinalight, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K172536

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
187d slower than avg
Panel avg: 115d · This submission: 302d
Pathway characteristics
Predicate-based equivalence.

LXM Device Classification - Class 0,

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

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