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510(k) K024169

MACROPORE OS RECONSTRUCTION by Macropore Biosurgery, Inc. — Product Code EZX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2003
Date Received
December 18, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Macropore Biosurgery, Inc.

  • K042261 — MACROPORE PURICEL LIPOPLASTY SYSTEM (September 20, 2004)
  • K041105 — MACROPORE HYDROSORB SPINE SYSTEM (July 28, 2004)
  • K031955 — MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET (September 22, 2003)
  • K031785 — MACROPORE CARDIO-WRAP (TS) (September 4, 2003)
  • K023643 — MACROPORE SURGICAL BARRIER FILM (February 21, 2003)
  • K021164 — MACROPORE OS TRAUMA (July 1, 2002)
  • K012025 — MACROPORE SURGIWRAP (TS) (December 3, 2001)
  • K012769 — MACROPORE ENT RECONSTRUCTION FILM (October 25, 2001)
  • K012413 — MACROPORE FX, PS, NS, LP (September 18, 2001)
  • K011715 — MACROPORE IB RESORBABLE PLUG (August 27, 2001)

Other clearances for product code EZX

  • K063461 — ANOVA CONTAINMENT DEVICE (August 13, 2009)
  • K014200 — OPTIMESH (November 26, 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)
  • K023882 — THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM (February 19, 2003)
  • K020853 — NUVASIVE MESH (June 13, 2002)
  • K983766 — SYNTHES SYNMESH (December 18, 1998)
  • K945027 — TROCHANTER MESH (February 1, 1995)
  • K900138 — MOTECH TITANIUM SURGICAL MESH (March 20, 1990)
  • K896369 — TITANIUM MESH MAXILLOFACIAL IMPLANT SYSTEM (November 24, 1989)