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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, femorotibial, semi-constrained, cemented, metal/polymer
510(k) Number K955778
Device Name NATURAL-KNEE II UNICOMPARTMENTALKNEE SYSTEM
Applicant
INTERMEDICS ORTHOPEDICS
9900 SPECTRUM DR.
AUSTIN,  TX  78717
Applicant Contact MITCHELL A DHORITY
Correspondent
INTERMEDICS ORTHOPEDICS
9900 SPECTRUM DR.
AUSTIN,  TX  78717
Correspondent Contact MITCHELL A DHORITY
Regulation Number888.3530
Classification Product Code
HRY  
Date Received12/20/1995
Decision Date 03/08/1996
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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