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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Hemi-, Femoral, Metal
510(k) Number K940190
Device Name ULTIMA UNIPOLAR MODULAR HEAD
Applicant
Johnson & Johnson Orthopaedics, Inc.
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact MARSHA J STONE
Correspondent
Johnson & Johnson Orthopaedics, Inc.
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact MARSHA J STONE
Regulation Number888.3360
Classification Product Code
KWL  
Date Received01/13/1994
Decision Date 09/29/1994
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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