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510(k) K945027

Device
TROCHANTER MESH
Applicant
ACUMED, INC.
510(k) number
K945027
Product code
EZX  
Decision
Substantially Equivalent For Some Indications (SN)
Decision date
1995-02-01
Date received
1994-10-13
Regulation
878.3300
Classification name
Mesh, Surgical, Metal
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
SHARI L JEFFERS
Address
10950 SW 5th St. Suite 170 Beaverton OR US 97005 97005

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K020853NUVASIVE MESHNuvasive, Inc.2002-06-13
K983766SYNTHES SYNMESHSynthes (Usa)1998-12-18
K900138MOTECH TITANIUM SURGICAL MESHBiedermann Motech GmbH1990-03-20
K896369TITANIUM MESH MAXILLOFACIAL IMPLANT SYSTEMTechmedica, Inc.1989-11-24
K890601STUART TITANIUM SURGICAL MESHStuart1989-03-16

Legacy Summary#

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FDA Review#

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