Cleared Traditional

K160278 - VSTAAR AdjusteR (FDA 510(k) Clearance)

K160278 · Spinal Acoustics, LLC · Physical Medicine device
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Nov 2016
Decision
276d
Days
-
Risk

K160278 is an FDA 510(k) clearance for the VSTAAR AdjusteR. Classified as Manipulator, Plunger-like Joint (product code LXM).

Submitted by Spinal Acoustics, LLC (Beaver, US). The FDA issued a Cleared decision on November 4, 2016 after a review of 276 days - an extended review 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: 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.

View all Spinal Acoustics, LLC devices

Submission Details

510(k) Number K160278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2016
Decision Date November 04, 2016
Days to Decision 276 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
161d slower than avg
Panel avg: 115d · This submission: 276d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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