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510(k) K103517

TRABECULAR METAL FEMORAL CONE AUGMENTS by Zimmer Trabecular Metal Technology, Inc. — Product Code MBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2011
Date Received
November 30, 2010
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, Inc.

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  • 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)
  • 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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