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510(k) K945027

TROCHANTER MESH by Acu Med, Inc. — Product Code EZX

K945027 is an FDA 510(k) premarket notification submitted by Acu Med, Inc. for the device "TROCHANTER MESH". The FDA issued a decision of SN on February 1, 1995. The device falls under product code EZX (Mesh, Surgical, Metal), a Class II device regulated under 21 CFR 878.3300. Acu Med, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
February 1, 1995
Date Received
October 13, 1994
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 Acu Med, Inc.

  • K021321 — WRIST FUSION PLATE (July 17, 2002)
  • K013616 — POLARUS CAP SCREW (December 19, 2001)
  • K012655 — CONGRUENT BONE PLATE SYSTEM (November 7, 2001)
  • K992525 — ACUMED MODULAR SHOULDER SYSTEM (February 4, 2000)
  • K993657 — ACUMED SUTURE ANCHOR (January 13, 2000)
  • K980103 — ACUMED SUTURE ANCHOR (March 16, 1998)
  • K965028 — ACUMED SUTURE WASHER (March 17, 1997)
  • K965029 — STABLELOC II EXTERNAL FIXATOR (February 19, 1997)
  • K964500 — ACUMED TENSION BAND PIN (December 9, 1996)
  • K963026 — TBD (October 28, 1996)

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)
  • K900138 — MOTECH TITANIUM SURGICAL MESH (March 20, 1990)
  • K896369 — TITANIUM MESH MAXILLOFACIAL IMPLANT SYSTEM (November 24, 1989)

FDA data resources