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510(k) K972760

Device
LINK, ACETABULAR REVISION MESH CUP
Applicant
LINK AMERICA, INC.
510(k) number
K972760
Product code
JDJ  
Decision
Substantially Equivalent (SESE)
Decision date
1997-10-22
Date received
1997-07-24
Regulation
878.3300
Classification name
Mesh, Surgical, Acetabular, Hip, Prosthesis
Medical specialty
General & Plastic Surgery
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
DOUGLAS W STUART
Address
321 Palmer Rd. Denville NJ US 07834 07834

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JDJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K970957OSTEONICS RESTORATION ACETABULAR RINGOsteonics Corp.1997-06-03
K963940EXETER MESHHowmedica, Inc.1997-02-13
K962541REFLECTION ACETABULAR REINFORCEMENT RINGSSmith & Nephew Richards, Inc.1996-09-17
K962007PROTRUSION CAGESDepuy, Inc.1996-08-01
K925883OSTEONICS MICROSTRUCTURED ACETABULAR COMPONENTSOsteonics Corp.1993-06-15
K890450INTERMEDICS APR(TM) II FEMORAL COMPONENTIntermedics Orthopedics1989-08-09

Legacy Summary#

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FDA Review#

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