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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 K934695
Device Name NATURAL-KNEE TIBIAL BASEPLATE/ALL POLY PATELLA
Applicant
INTERMEDICS ORTHOPEDICS
9900 SPECTRUM DR.
AUSTIN,  TX  78717
Applicant Contact MITCHELL DHORITY
Correspondent
INTERMEDICS ORTHOPEDICS
9900 SPECTRUM DR.
AUSTIN,  TX  78717
Correspondent Contact MITCHELL DHORITY
Regulation Number888.3560
Classification Product Code
JWH  
Date Received09/30/1993
Decision Date 05/02/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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