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510(k) K061155

VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM by Zimmer Trabecular — Product Code MQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 2006
Date Received
April 26, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spinal Vertebral Body Replacement Device
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

Other clearances by Zimmer Trabecular

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  • 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)
  • 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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