Cleared Traditional

K072519 - ACTIVATOR V SPINAL ADJUSTING INSTRUMENT

K072519 · Activator Methods International, Ltd. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
46d
Days
-
Risk

K072519 is an FDA 510(k) clearance for the ACTIVATOR V SPINAL ADJUSTING INSTRUMENT. Classified as Manipulator, Plunger-like Joint (product code LXM).

Submitted by Activator Methods International, Ltd. (Mesa, US). The FDA issued a Cleared decision on October 23, 2007 after a review of 46 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K072519

510(k) Number K072519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2007
Decision Date October 23, 2007
Days to Decision 46 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
70d faster than avg
Panel avg: 116d · This submission: 46d
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

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K072519 · ACTIVATOR V SPINAL ADJUSTING INSTRUMENT
Download PDF FDA Summary Activator Methods Int…