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510(k) K140359

MAXIMIS SPINAL FIXATION SYSTEM by Valorem Surgical — Product Code MNH

K140359 is an FDA 510(k) premarket notification submitted by Valorem Surgical for the device "MAXIMIS SPINAL FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on January 7, 2015. The device falls under product code MNH (Orthosis, Spondylolisthesis Spinal Fixation), a Class II device regulated under 21 CFR 888.3070.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2015
Date Received
February 12, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Spondylolisthesis Spinal Fixation
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Other clearances for product code MNH

  • K162066 — Reliance Spinal Screw System (December 2, 2016)
  • K162801 — CastleLoc Spinal Fixation System (November 3, 2016)
  • K162143 — FixxSure® X-Link (September 23, 2016)
  • K161151 — Spinal fixation system (September 21, 2016)
  • K162189 — ANAX™ 5.5 Spinal System (August 30, 2016)
  • K151362 — HC Spinal System (May 5, 2016)
  • K153404 — Zavation Spinal System (April 21, 2016)
  • K160020 — Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System (March 2, 2016)
  • K143013 — Spinal Inner Fixation System (December 11, 2015)
  • K151695 — Romeo posterior osteosynthesis system (September 10, 2015)

FDA data resources