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510(k) K983766

SYNTHES SYNMESH by Synthes (Usa) — Product Code EZX

K983766 is an FDA 510(k) premarket notification submitted by Synthes (Usa) for the device "SYNTHES SYNMESH". The FDA issued a decision of Substantially Equivalent on December 18, 1998. The device falls under product code EZX (Mesh, Surgical, Metal), a Class II device regulated under 21 CFR 878.3300. Synthes (Usa) has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1998
Date Received
October 26, 1998
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 Synthes (Usa)

  • K180821 — TruMatch Graft Cage - Long Bone (December 21, 2018)
  • K152239 — Zero-P Natural Plate System (December 2, 2015)
  • K131984 — SYNTHES SYNSONIC ULNA NAIL (March 31, 2014)
  • K130146 — SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM (May 20, 2013)
  • K120275 — SYNTHES ACIS/VERTEBRAL SPACER CR (May 25, 2012)
  • K111667 — SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS (December 5, 2011)
  • K111540 — SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM (August 8, 2011)
  • K110789 — SYNTHES STERNAL ZIPFIX SYSTEM (July 28, 2011)
  • K103002 — SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM (March 2, 2011)
  • K103243 — 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM (January 21, 2011)

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)
  • 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