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510(k) K070754

TRABECULAR METAL VERTEBRAL BODY REPLACEMENT (VBR), MODEL# 06-115, 06-155 by Zimmer Trabecular Metal Technology — Product Code MQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2007
Date Received
March 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

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  • 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)
  • K093127 — TRABECULAR METAL (TM) VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM INSTRUMENT SET (March 4, 2010)

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