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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K000590
Device Name LATERAL PIVOT INSERT
Applicant
Encore Orthopedics, Inc.
9800 Metric Blvd.
Austin,  TX  78758
Applicant Contact DEBBIE DE LOS SANTOS
Correspondent
Encore Orthopedics, Inc.
9800 Metric Blvd.
Austin,  TX  78758
Correspondent Contact DEBBIE DE LOS SANTOS
Regulation Number888.3560
Classification Product Code
JWH  
Date Received02/21/2000
Decision Date 05/11/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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