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510(k) K093127

TRABECULAR METAL (TM) VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM INSTRUMENT SET by Zimmer Trabecular Metal Technology — Product Code MQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 2010
Date Received
October 2, 2009
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 Zimmer Trabecular Metal Technology

  • K133784 — VISTA-S DEVICE, ASSOCIATED INSTRUMENTATION (July 7, 2014)
  • K123602 — TM ARDIS INTERBODY SYSTEM INSERTER (March 1, 2013)
  • K120990 — NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LC (June 29, 2012)
  • K120203 — TM-400 DEVICE (June 15, 2012)
  • K113561 — TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION (May 29, 2012)
  • K111983 — VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX (November 18, 2011)
  • K103517 — TRABECULAR METAL FEMORAL CONE AUGMENTS (February 15, 2011)
  • K103033 — TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXX (January 10, 2011)
  • K102896 — TRABECULAR METAL TIBIAL CONE AUGMENTS (December 13, 2010)
  • K070754 — TRABECULAR METAL VERTEBRAL BODY REPLACEMENT (VBR), MODEL# 06-115, 06-155 (August 31, 2007)

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