Cleared Traditional

K160278 - VSTAAR AdjusteR

K160278 · Spinal Acoustics, LLC · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K160278

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
160d slower than avg
Panel avg: 116d · This submission: 276d
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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K160278 · VSTAAR AdjusteR
Download PDF FDA Summary Spinal Acoustics, LLC