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510(k) K900138

MOTECH TITANIUM SURGICAL MESH by Biedermann Motech GmbH — Product Code EZX

K900138 is an FDA 510(k) premarket notification submitted by Biedermann Motech GmbH for the device "MOTECH TITANIUM SURGICAL MESH". The FDA issued a decision of Substantially Equivalent on March 20, 1990. The device falls under product code EZX (Mesh, Surgical, Metal), a Class II device regulated under 21 CFR 878.3300. Biedermann Motech GmbH has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 1990
Date Received
January 11, 1990
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 Biedermann Motech GmbH

  • K894184 — BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEM (April 25, 1990)

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)
  • 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)
  • K896369 — TITANIUM MESH MAXILLOFACIAL IMPLANT SYSTEM (November 24, 1989)

FDA data resources