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510(k) K081631

SINTEA BIOTECH PLS MULTI-AXIAL SCREWS by Sintea Biotech, Inc. — Product Code MNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2008
Date Received
June 11, 2008
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 Sintea Biotech, Inc.

  • K082679 — LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X (April 7, 2009)
  • K072198 — X-VOID, SPIDER (June 6, 2008)
  • K070181 — SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XX (April 18, 2007)
  • K060513 — SINTEA BIOTECH PLS MULTI-AXIAL SCREWS, MODEL PLS.XX.T5.X (March 10, 2006)
  • K043355 — SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS, MODEL (December 17, 2004)
  • K041989 — SINTEA BIOTECH ANTERIOR PLATE SYSTEM, MODEL ACP.XX.T5.X (September 16, 2004)
  • K031154 — SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.X (June 24, 2003)
  • K020085 — SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM, MODEL PLS 00.T5.X (December 10, 2002)
  • K022065 — SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X (August 6, 2002)

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)