FDA.reportPublic FDA data

510(k) K033384

Device
THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ
Applicant
Implex Corp.
510(k) number
K033384
Product code
JDK
Decision
Substantially Equivalent (SESE)
Decision date
2003-11-19
Date received
2003-10-23
Regulation
878.3300
Classification name
Prosthesis, Hip, Cement Restrictor
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MARCI HALEVI
Address
80 Commerce Dr. Allendale NJ US 07401 07401

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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K210062Mectaplug PE IIMedacta International S.A.2021-04-08
K061465KMI CEMENT RESTRICTOR IMPLANTKinetikos Medical, Inc.2006-10-05
K061698MODIFICATION TO LIFE SPINE CEMENT RESTRICTORLife Spine2006-07-12
K060247LIFE SPINE CEMENT RESTRICTORLife Spine2006-05-11
K060132SPINAL USA CEMENT RESTRICTOR SYSTEMSpinal USA2006-03-16
K051371INTERBODY INNOVATIONS CEMENT RESTRICTORInterbody Innovations, Llp2005-12-06
K051836SKELITE RESORBABLE CEMENT RESTRICTORMillenium Biologix, Inc.2005-11-21
K051607NOVASPINE CEMENT RESTRICTOR NSCRNovaspine, LLC2005-10-07
K052367SCIENT'X CEMENT RESTRICTORScient'X2005-10-05
K041382POLYGRAFT BGS; BONE GRAFT SUBSTITUTEOsteobiologics, Inc.2005-06-17
K050699MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004Amedica Corp.2005-04-15
K041583PEEK CEMENT RESTRICTOR X-BOXInnovasis, Inc.2004-07-22
K033953OPTIMESH 500E CEMENT RESTRICTORSpineology, Inc.2004-07-06
K040276QUANTUM CEMENT RESTRICTORQuantum Orthopedics2004-04-30
K030767FIDJI SMALL CEMENT RESTRICTORSpine Next SA2003-12-22