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510(k) K152324

YAHUA Spinal System by Beijing Weigao Yahua Artificial Joint Development Co. , Ltd. — Product Code MNI

K152324 is an FDA 510(k) premarket notification submitted by Beijing Weigao Yahua Artificial Joint Development Co. , Ltd. for the device "YAHUA Spinal System". The FDA issued a decision of Substantially Equivalent on February 1, 2016. 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
February 1, 2016
Date Received
August 17, 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 (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)
  • K143222 — FIREFLY Pedicle Screw Navigation Guide (December 11, 2015)
  • K150684 — WASTON General Spinal System (November 18, 2015)
  • K152132 — X-spine Pedicle Screw System (September 25, 2015)

FDA data resources