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510(k) K152098

ODALYS Pedicle Screw System by Kisco International — Product Code MNI

K152098 is an FDA 510(k) premarket notification submitted by Kisco International for the device "ODALYS Pedicle Screw System". The FDA issued a decision of Substantially Equivalent on Sep 17, 2015. The device falls under product code MNI (Orthosis, Spinal Pedicle Fixation), a Class II device regulated under 21 CFR 888.3070.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Sep 17, 2015
Date Received
Jul 28, 2015
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 for product code MNI

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

FDA data resources