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510(k) K020853

Device
NUVASIVE MESH
Applicant
Nuvasive, Inc.
510(k) number
K020853
Product code
EZX
Decision
Substantially Equivalent (SESE)
Decision date
2002-06-13
Date received
2002-03-15
Regulation
878.3300
Classification name
Mesh, Surgical, Metal
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
LAETITIA BERNARD
Address
10065 Old Grove Rd. San Diego CA US 92131 92131

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EZX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K063461ANOVA CONTAINMENT DEVICEAnova Corporation2009-08-13
K014200OPTIMESHSpineology, Inc.2003-11-26
K032344THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330Implex Corp.2003-10-02
K032282MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEMImplex Corp.2003-08-21
K024169MACROPORE OS RECONSTRUCTIONMacropore Biosurgery, Inc.2003-07-01
K023882THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEMImplex Corp.2003-02-19
K983766SYNTHES SYNMESHSynthes (Usa)1998-12-18
K945027TROCHANTER MESHAcu Med, Inc.1995-02-01
K900138MOTECH TITANIUM SURGICAL MESHBiedermann Motech GmbH1990-03-20
K896369TITANIUM MESH MAXILLOFACIAL IMPLANT SYSTEMTechmedica, Inc.1989-11-24
K890601STUART TITANIUM SURGICAL MESHStuart1989-03-16