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510(k) K160278

VSTAAR AdjusteR by Spinal Acoustics, LLC — Product Code LXM

K160278 is an FDA 510(k) premarket notification submitted by Spinal Acoustics, LLC for the device "VSTAAR AdjusteR". The FDA issued a decision of Substantially Equivalent on November 4, 2016. The device falls under product code LXM (Manipulator, Plunger-Like Joint), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2016
Date Received
February 2, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Manipulator, Plunger-Like Joint
Device Class
Class U
Regulation Number
Review Panel
PM
Submission Type

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  • K130666 — KHAN KINETIC TREATMENT (KKT-M2) (January 23, 2014)
  • K112606 — ACTIVATOR V-E (March 6, 2012)
  • K082218 — MAX ADJUSTING INSTRUMENT (August 13, 2008)
  • K080261 — IMPULSE IQ ADJUSTING INSTRUMENT (April 11, 2008)
  • K072519 — ACTIVATOR V SPINAL ADJUSTING INSTRUMENT (October 23, 2007)
  • K060043 — KHAN KINETIC TREATMENT DEVICE (KKT-M1) (March 23, 2006)
  • K050428 — TECHNOLOGY-ASSISTED MICRO-MOBILIZATION AND REFLEX STIMULATOR (TAMARS) (June 14, 2005)

FDA data resources