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510(k) K031449

MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION by Implex Corp. — Product Code KWS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2003
Date Received
May 7, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Device Class
Class II
Regulation Number
888.3660
Review Panel
OR
Submission Type

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  • K040487 — TRABECULAR METAL KNEE SYSTEM AUGMENTS (December 21, 2004)
  • K040630 — TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZ (September 30, 2004)
  • K040756 — THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX (July 14, 2004)
  • K031962 — NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS (January 8, 2004)
  • K033384 — THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ (November 19, 2003)
  • K032527 — HEDROCEL VERTEBRAL BODY REPLACEMENT (October 31, 2003)
  • K032344 — THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330 (October 2, 2003)
  • K032282 — MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM (August 21, 2003)

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