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510(k) K073531

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

K073531 is an FDA 510(k) premarket notification submitted by Accelerated Innovation, LLC for the device "ACCIN PEDICLE SCREW SYSTEM". The FDA issued a decision of Substantially Equivalent on February 4, 2008. The device falls under product code MNH (Orthosis, Spondylolisthesis Spinal Fixation), a Class II device regulated under 21 CFR 888.3070. Accelerated Innovation, LLC has at least 6 other 510(k) clearances on record.

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)

Other clearances for product code MNH

  • K162066 — Reliance Spinal Screw System (December 2, 2016)
  • K162801 — CastleLoc Spinal Fixation System (November 3, 2016)
  • K162143 — FixxSure® X-Link (September 23, 2016)
  • 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)

FDA data resources