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510(k) K073531

ACCIN PEDICLE SCREW SYSTEM by Accelerated Innovation, LLC — Product Code MNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2008
Date Received
December 17, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Spondylolisthesis Spinal Fixation
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Other clearances by Accelerated Innovation, LLC

  • K081127 — ACCIN TOTAL KNEE SYSTEM (October 17, 2008)
  • K080647 — ACCIN BIPOLAR HEAD SYSTEM (July 8, 2008)
  • K080539 — ACCIN UNIPOLAR HEAD SYSTEM (June 2, 2008)
  • K073120 — ACCIN PATELLOFEMORAL SYSTEM (February 29, 2008)
  • K073530 — ACCIN ANTERIOR CERVICAL PLATE SYSTEM (January 31, 2008)
  • K073068 — ACCIN HIP SYSTEM (January 10, 2008)

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  • K161151 — Spinal fixation system (September 21, 2016)
  • K162189 — ANAX™ 5.5 Spinal System (August 30, 2016)
  • K151362 — HC Spinal System (May 5, 2016)
  • K153404 — Zavation Spinal System (April 21, 2016)
  • K160020 — Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System (March 2, 2016)
  • K143013 — Spinal Inner Fixation System (December 11, 2015)
  • K151695 — Romeo posterior osteosynthesis system (September 10, 2015)