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510(k) K033826

ORTHOPEDIC ALLIANCE SPINE SYSTEM by Orthopedic Alliance, LLC — Product Code MNI

K033826 is an FDA 510(k) premarket notification submitted by Orthopedic Alliance, LLC for the device "ORTHOPEDIC ALLIANCE SPINE SYSTEM". The FDA issued a decision of Substantially Equivalent on July 1, 2004. The device falls under product code MNI (Orthosis, Spinal Pedicle Fixation), a Class II device regulated under 21 CFR 888.3070. Orthopedic Alliance, LLC has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2004
Date Received
December 10, 2003
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 Orthopedic Alliance, LLC

  • K052237 — SC CERAMIC BALL HEADS (September 6, 2005)
  • K031474 — SC TOTAL HIP SYSTEM (October 15, 2003)

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