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510(k) K050101

THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-10 by Zimmer Trabecular — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2005
Date Received
January 18, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Zimmer Trabecular

  • K061155 — VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM (September 22, 2006)
  • K061067 — TRABECULAR METAL ACETABULAR AUGMENTS (May 25, 2006)
  • K053340 — TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS (February 27, 2006)
  • K052950 — THE ZIMMER TMT TRABECULAR METAL VERTEBRAL BODY REPLACEMENT SYSTEM (November 16, 2005)
  • 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)
  • 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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