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510(k) K955540

HAND HELD ATLAS INSTRUMENT by Spinalight, Inc. — Product Code LXM

K955540 is an FDA 510(k) premarket notification submitted by Spinalight, Inc. for the device "HAND HELD ATLAS INSTRUMENT". The FDA issued a decision of Substantially Equivalent on March 4, 1996. The device falls under product code LXM (Manipulator, Plunger-Like Joint), a Class U device. Spinalight, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1996
Date Received
December 5, 1995
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

Other clearances by Spinalight, Inc.

  • K172536 — Atlas Percussion Adjusting Instrument (June 20, 2018)
  • K001476 — TORQUE INSTRUMENT, MODEL 8500 (August 4, 2000)
  • K946258 — MODEL 8000 ATLAS C-1 ORTHOGONAL ADJUSTING INSTRUMENT (November 20, 1995)
  • K945954 — MODELS 4100 AND 4300 MULTITHERAPY (January 19, 1995)
  • K933621 — HILO TABLE (January 7, 1994)
  • K933622 — FLEXION DISTRACTION TABLE (January 7, 1994)

Other clearances for product code LXM

  • K234036 — SONIK MONARK 100 (February 15, 2024)
  • K192629 — Spinalytics (December 21, 2019)
  • K172536 — Atlas Percussion Adjusting Instrument (June 20, 2018)
  • K160278 — VSTAAR AdjusteR (November 4, 2016)
  • 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)

FDA data resources