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510(k) K043001

MX POLYAXIAL PEDICLE SCREW by Scient'X — Product Code MNH

K043001 is an FDA 510(k) premarket notification submitted by Scient'X for the device "MX POLYAXIAL PEDICLE SCREW". The FDA issued a decision of Substantially Equivalent on December 1, 2004. The device falls under product code MNH (Orthosis, Spondylolisthesis Spinal Fixation), a Class II device regulated under 21 CFR 888.3070. Scient'X has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 2004
Date Received
November 1, 2004
Clearance Type
Special
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 Scient'X

  • K071261 — ISOBAR SEMI-RIGID DUAL DAMPENER (April 17, 2008)
  • K062912 — SCIENT'X SPINAL SYSTEM (February 5, 2007)
  • K052763 — STELLA CERVICAL PLATE (November 10, 2005)
  • K052367 — SCIENT'X CEMENT RESTRICTOR (October 5, 2005)
  • K050348 — CO VERTEBRAL BODY REPLACEMENT (May 27, 2005)
  • K051063 — POLYAXIAL HEMISPHERICAL SPINAL SCREWS (May 23, 2005)
  • K042964 — MX MONOAXIAL PEDICLE SCREW (November 22, 2004)
  • K042317 — CERVICAL PLATE (September 24, 2004)
  • K040747 — ALADYN RIGID SPINE PLATE (June 17, 2004)
  • K040454 — BIOFILL BONE VOID FILLER (May 7, 2004)

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