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510(k) K020853

NUVASIVE MESH by Nuvasive, Inc. — Product Code EZX

K020853 is an FDA 510(k) premarket notification submitted by Nuvasive, Inc. for the device "NUVASIVE MESH". The FDA issued a decision of Substantially Equivalent on June 13, 2002. The device falls under product code EZX (Mesh, Surgical, Metal), a Class II device regulated under 21 CFR 878.3300. Nuvasive, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2002
Date Received
March 15, 2002
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 Nuvasive, Inc.

  • K233706 — Bendini Cloud Application (August 2, 2024)
  • K240507 — NuVasive AttraX Scaffold (March 20, 2024)
  • K223731 — NuVasive Modulus-C Interbody System (January 12, 2023)
  • K211757 — Simplify Disc (August 20, 2021)
  • K173117 — NuVasive® VersaTie™ System (December 7, 2017)
  • K141665 — NuVasive CoRoent System (March 13, 2015)
  • K142205 — NuVasive X-CORE(R) Expandable VBR System (February 20, 2015)
  • K141968 — NUVASIVE NVM5 SYSTEM (November 14, 2014)
  • K140319 — COROENT TI-C SYSTEM (October 9, 2014)
  • K140162 — AP EXPANDABLE XLIF SYSTEM (July 2, 2014)

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)
  • 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