Home / 510(k) Clearances / K081153

510(k) K081153

NOVEL SPINAL SYSTEM by Medyssey Co, Ltd. — Product Code MNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2009
Date Received
April 23, 2008
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 by Medyssey Co, Ltd.

  • K242806 — Medyssey Navigation System (April 16, 2025)
  • K121670 — MEDYSSEY CANNULATED PEDICLE SCREW (January 25, 2013)
  • K121320 — C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE (August 10, 2012)
  • K121246 — MEDYSSY LT CAGE SYSTEM (June 15, 2012)
  • K110284 — NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM (June 8, 2011)
  • K110283 — ZENIUS SPINAL SYSTEM (May 19, 2011)
  • K110067 — LP CAGE (April 8, 2011)
  • K103272 — ZENIUS SPINAL SYSTEM (December 29, 2010)
  • K103147 — NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM (December 16, 2010)
  • K093104 — MEDYSSEY CO., LTD., ZENIUS SPINAL SYSTEM (June 25, 2010)

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)