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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 K023528
Device Name NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE
Applicant
CENTERPLUS ORTHOPEDICS, INC
9900 SPECTRUM DR.
AUSTIN,  TX  78717
Applicant Contact MITCHELL A DHORITY
Correspondent
CENTERPLUS ORTHOPEDICS, INC
9900 SPECTRUM DR.
AUSTIN,  TX  78717
Correspondent Contact MITCHELL A DHORITY
Regulation Number888.3560
Classification Product Code
JWH  
Date Received10/21/2002
Decision Date 01/17/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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