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510(k) K040756

THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX by Implex Corp. — Product Code FTM

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 14, 2004
Date Received: March 24, 2004
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Mesh, Surgical
Device Class: Class II
Regulation Number: 878.3300
Review Panel: SU
Submission Type

Other clearances by Implex Corp.

K051978 — TRABECULAR METAL VERTEBRAL BODY REPLACEMENT (September 23, 2005)
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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)
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)
K032282 — MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM (August 21, 2003)

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