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510(k) K121172

REFORM PEDICLE SCREW SYSTEM by Spinal USA — Product Code MNI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2012
Date Received
April 17, 2012
Clearance Type
Special
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 Spinal USA

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  • K131343 — REFORM PEDICLE SCREW SYSTEM (July 24, 2013)
  • K130279 — REFORM PEDICLE SCREW SYSTEM (June 20, 2013)
  • K130445 — VAULT ALIF SYSTEM (April 25, 2013)
  • K122931 — S-LOK PSS SYSTEM (November 20, 2012)
  • K112748 — SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEM (July 11, 2012)
  • K112025 — SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM (September 15, 2011)
  • K103369 — VAULT ALIF SYSTEM (April 4, 2011)
  • K092659 — SPINAL USA RCS ANTERIOR LUMBAR BUTRESS PLATE SYSTEM, MODEL 22-1001-25 (November 17, 2009)

Other clearances for product code MNI

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  • 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)