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510(k) K946258

MODEL 8000 ATLAS C-1 ORTHOGONAL ADJUSTING INSTRUMENT by Spinalight, Inc. — Product Code LXM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 1995
Date Received
December 6, 1994
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.

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  • K945954 — MODELS 4100 AND 4300 MULTITHERAPY (January 19, 1995)
  • K933621 — HILO TABLE (January 7, 1994)
  • K933622 — FLEXION DISTRACTION TABLE (January 7, 1994)

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  • 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)