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510(k) K001476

TORQUE INSTRUMENT, MODEL 8500 by Spinalight, Inc. — Product Code LXM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 2000
Date Received
May 11, 2000
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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  • 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)