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510(k) K133690

TRUE SPINAL FUSSION SYSTEM by Innovative Surgical Designs — Product Code MNH

K133690 is an FDA 510(k) premarket notification submitted by Innovative Surgical Designs for the device "TRUE SPINAL FUSSION SYSTEM". The FDA issued a decision of Substantially Equivalent on May 7, 2014. The device falls under product code MNH (Orthosis, Spondylolisthesis Spinal Fixation), a Class II device regulated under 21 CFR 888.3070. Innovative Surgical Designs has 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 2014
Date Received
Dec 2, 2013
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
510(k)

Other clearances by Innovative Surgical Designs

  • K220297 — True Tulip, True M.I.S. (Sep 16, 2022)
  • K212627 — True Tulip, True M.I.S. (Feb 18, 2022)
  • K210816 — True Tulip, True M.I.S. (May 18, 2021)
  • K201780 — True Tulip System, True M.I.S. System (Jul 22, 2020)
  • K181584 — Redi-Spine (Aug 10, 2018)
  • K171559 — True Spinal Fixation System (Jul 24, 2017)
  • K170710 — True Spinal Fixation System (Jul 14, 2017)
  • K130958 — TRUE SPINAL FIXATION SYSTEM (Oct 17, 2013)

Other clearances for product code MNH

  • K162066 — Reliance Spinal Screw System (Dec 2, 2016)
  • K162801 — CastleLoc Spinal Fixation System (Nov 3, 2016)
  • K162143 — FixxSure® X-Link (Sep 23, 2016)
  • K161151 — Spinal fixation system (Sep 21, 2016)
  • K162189 — ANAX™ 5.5 Spinal System (Aug 30, 2016)
  • K151362 — HC Spinal System (May 5, 2016)
  • K153404 — Zavation Spinal System (Apr 21, 2016)
  • K160020 — Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System (Mar 2, 2016)
  • K143013 — Spinal Inner Fixation System (Dec 11, 2015)
  • K151695 — Romeo posterior osteosynthesis system (Sep 10, 2015)

FDA data resources