Home / 510(k) Clearances / K051756

510(k) K051756

MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZ by Zimmer Trabecular — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2005
Date Received
June 29, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3560
Review Panel
OR
Submission Type

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  • K052950 — THE ZIMMER TMT TRABECULAR METAL VERTEBRAL BODY REPLACEMENT SYSTEM (November 16, 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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