Home / 510(k) Clearances / K890601

510(k) K890601

STUART TITANIUM SURGICAL MESH by Stuart — Product Code EZX

K890601 is an FDA 510(k) premarket notification submitted by Stuart for the device "STUART TITANIUM SURGICAL MESH". The FDA issued a decision of Substantially Equivalent on March 16, 1989. The device falls under product code EZX (Mesh, Surgical, Metal), a Class II device regulated under 21 CFR 878.3300. Stuart has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1989
Date Received
February 6, 1989
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 Stuart

  • K897141 — SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIO (June 21, 1990)
  • K851414 — SEGMENTAL SPINAL RODS (June 28, 1985)
  • K843445 — SACRAL BAR (February 13, 1985)
  • K820034 — ANTERIOR DISTRACTION SYSTEM (March 11, 1982)

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)
  • K900138 — MOTECH TITANIUM SURGICAL MESH (March 20, 1990)

FDA data resources