Home / 510(k) Clearances / K093104

510(k) K093104

MEDYSSEY CO., LTD., ZENIUS SPINAL SYSTEM by Medyssey Co, Ltd. — Product Code MNI

K093104 is an FDA 510(k) premarket notification submitted by Medyssey Co, Ltd. for the device "MEDYSSEY CO., LTD., ZENIUS SPINAL SYSTEM". The FDA issued a decision of Substantially Equivalent on June 25, 2010. The device falls under product code MNI (Orthosis, Spinal Pedicle Fixation), a Class II device regulated under 21 CFR 888.3070. Medyssey Co, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2010
Date Received
October 1, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Medyssey Co, Ltd.

  • K260036 — NeckTune™ 3D SA Cervical Cage (June 15, 2026)
  • 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)

Other clearances for product code MNI

  • K171497 — Mikron Spinal Fixation System (October 12, 2017)
  • K160731 — LumFix Spinal Fixation Sytem (October 4, 2016)
  • K151458 — Double Medical Universal Spine System (August 22, 2016)
  • K153273 — MySpine Pedicle Screw Placement Guides - LP (June 29, 2016)
  • K160124 — LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation (April 4, 2016)
  • K160320 — Premier (April 1, 2016)
  • K160003 — Sniper (R) Spine System (February 26, 2016)
  • K152324 — YAHUA Spinal System (February 1, 2016)
  • K143222 — FIREFLY Pedicle Screw Navigation Guide (December 11, 2015)
  • K150684 — WASTON General Spinal System (November 18, 2015)

FDA data resources