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510(k) K120990

NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL by Zimmer Trabecular Metal Technology — Product Code MBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2012
Date Received
April 2, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3565
Review Panel
OR
Submission Type

Other clearances by Zimmer Trabecular Metal Technology

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  • 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)
  • K093127 — TRABECULAR METAL (TM) VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM INSTRUMENT SET (March 4, 2010)
  • K070754 — TRABECULAR METAL VERTEBRAL BODY REPLACEMENT (VBR), MODEL# 06-115, 06-155 (August 31, 2007)

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