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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 K936159
Device Name NATURAL-KNEE II SYSTEM
Applicant
INTERMEDICS ORTHOPEDICS
1300 EAST ANDERSON LN.
BUILDING C
AUSTIN,  TX  78752
Applicant Contact JOANN RINGER
Correspondent
INTERMEDICS ORTHOPEDICS
1300 EAST ANDERSON LN.
BUILDING C
AUSTIN,  TX  78752
Correspondent Contact JOANN RINGER
Regulation Number888.3560
Classification Product Code
JWH  
Date Received12/23/1993
Decision Date 05/22/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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