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510(k) K053340

TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS by Zimmer Trabecular — Product Code MBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2006
Date Received
December 1, 2005
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

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  • K051756 — MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZ (July 27, 2005)
  • K050766 — EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM (May 26, 2005)
  • K050937 — TRABECULAR METAL ACETABULAR REVISION SHELLS (May 11, 2005)
  • K050101 — THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-10 (April 15, 2005)
  • K042871 — TRABECULAR METAL ACETABULAR AUGMENTS, MODELS 4894-XXX-YY, 02-212-105XX3, 02-212- (December 21, 2004)
  • K043061 — THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, M (November 23, 2004)

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