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510(k) K031462

THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS by Implex Corp. — Product Code MBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2003
Date Received
May 8, 2003
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

Other clearances by Implex Corp.

  • K051978 — TRABECULAR METAL VERTEBRAL BODY REPLACEMENT (September 23, 2005)
  • K051196 — TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1 (June 17, 2005)
  • 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)
  • K031449 — MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOU (September 23, 2003)

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