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510(k) K061577

OVALTWIST PEDICLE SCREW SYSTEM by Signus Medizintechnik GmbH — Product Code MNH

K061577 is an FDA 510(k) premarket notification submitted by Signus Medizintechnik GmbH for the device "OVALTWIST PEDICLE SCREW SYSTEM". The FDA issued a decision of Substantially Equivalent on September 14, 2006. The device falls under product code MNH (Orthosis, Spondylolisthesis Spinal Fixation), a Class II device regulated under 21 CFR 888.3070. Signus Medizintechnik GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2006
Date Received
June 7, 2006
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 Signus Medizintechnik GmbH

  • K243188 — CYLOX® ST (February 11, 2025)
  • K241438 — Signus Tetris™ St; Signus Tetris™ R St (September 11, 2024)
  • K220658 — COSY Cervicothoracic Occipital Rod-Screw System (November 18, 2022)
  • K212755 — SIGNUS SACRONAIL® Transsacral Stabilization System (March 10, 2022)
  • K203327 — VERTACONNECT TLIF Cage (January 25, 2021)
  • K151704 — Diplomat® Spinal System (April 13, 2016)
  • K141405 — MOBIS II ST SPINAL IMPLANT (September 16, 2014)
  • K123758 — TASMIN R (January 14, 2014)
  • K131372 — MOBIS II (July 2, 2013)
  • K122317 — TETRIS II (August 29, 2012)

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