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510(k) K043355

SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS, MODEL PLS.01.T5.X by Sintea Biotech, Inc. — Product Code KWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2004
Date Received
December 6, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Interlaminal
Device Class
Class II
Regulation Number
888.3050
Review Panel
OR
Submission Type

Other clearances by Sintea Biotech, Inc.

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  • 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)
  • 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)

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