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510(k) K151458

Double Medical Universal Spine System by Double Medical Technology, Inc. — Product Code MNI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2016
Date Received
June 1, 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 by Double Medical Technology, Inc.

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  • K233078 — Posterior Cervical Spine System (November 22, 2023)
  • K223753 — Cervical Plate System (March 14, 2023)
  • K221150 — Advanced Bone Plate (January 25, 2023)
  • K221088 — Anatomic Bone Plate (January 18, 2023)
  • K221090 — Metal Cannulated Screw (January 10, 2023)
  • K221221 — Advanced Intramedullary Nail System (December 21, 2022)
  • K220921 — Metal Bone Screw (December 12, 2022)
  • K172830 — Double Medical Femoral Nail System (August 24, 2018)

Other clearances for product code MNI

  • K171497 — Mikron Spinal Fixation System (October 12, 2017)
  • K160731 — LumFix Spinal Fixation Sytem (October 4, 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)
  • K152132 — X-spine Pedicle Screw System (September 25, 2015)