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510(k) K871510

Device
MODIFIED PROFILE HIP PMMA CEMENT SPACER
Applicant
DEPUY, INC.
510(k) number
K871510
Product code
JDK  
Decision
Substantially Equivalent (SESE)
Decision date
1987-05-27
Date received
1987-04-15
Regulation
878.3300
Classification name
Prosthesis, Hip, Cement Restrictor
Medical specialty
General & Plastic Surgery
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
STEVEN J WENTWORTH
Address
P.O. Box 988 Warsaw IN US 46581 46581

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JDK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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

Legacy Summary#

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FDA Review#

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