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510(k) K063461

ANOVA CONTAINMENT DEVICE by Anova Corporation — Product Code EZX

K063461 is an FDA 510(k) premarket notification submitted by Anova Corporation for the device "ANOVA CONTAINMENT DEVICE". The FDA issued a decision of Substantially Equivalent on August 13, 2009. The device falls under product code EZX (Mesh, Surgical, Metal), a Class II device regulated under 21 CFR 878.3300.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2009
Date Received
November 15, 2006
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 for product code EZX

  • 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)
  • K024169 — MACROPORE OS RECONSTRUCTION (July 1, 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)

FDA data resources