Home / 510(k) Clearances / K070181

510(k) K070181

SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XX by Sintea Biotech, Inc. — Product Code MQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 2007
Date Received
January 19, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spinal Vertebral Body Replacement Device
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

Other clearances by Sintea Biotech, Inc.

  • K082679 — LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X (April 7, 2009)
  • K081631 — SINTEA BIOTECH PLS MULTI-AXIAL SCREWS (July 18, 2008)
  • K072198 — X-VOID, SPIDER (June 6, 2008)
  • 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 MQP

  • K253158 — VyBrate™ VBR System (January 7, 2026)
  • K241468 — Vertiwedge® Intraosseous System (November 7, 2024)
  • K232790 — KONG®-TL VBR System and KONG® C VBR System (April 4, 2024)
  • K233359 — DOMINION Expandable Corpectomy System (March 8, 2024)
  • K231134 — VerteLoc Spinal System (February 13, 2024)
  • K232173 — Ascend VBR System, Ascend NanoTec VBR System (October 6, 2023)
  • K211892 — ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) (October 6, 2022)
  • K202637 — F3D Corpectomy System (December 23, 2020)
  • K200235 — KONG-TL VBR System, KONG-C VBR System (May 29, 2020)
  • K193506 — NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable (February 26, 2020)