Cleared Traditional

K234036 - SONIK MONARK 100 (FDA 510(k) Clearance)

K234036 · Neuro Spinal Innovation, Inc. · Physical Medicine device
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Feb 2024
Decision
56d
Days
-
Risk

K234036 is an FDA 510(k) clearance for the SONIK MONARK 100. Classified as Manipulator, Plunger-like Joint (product code LXM).

Submitted by Neuro Spinal Innovation, Inc. (Mississauga, CA). The FDA issued a Cleared decision on February 15, 2024 after a review of 56 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.

View all Neuro Spinal Innovation, Inc. devices

Submission Details

510(k) Number K234036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2023
Decision Date February 15, 2024
Days to Decision 56 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
59d faster than avg
Panel avg: 115d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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