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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained
510(k) Number K911552
Device Name ANATOMIC TOE SYSTEM
Applicant
Orthopaedic Biosystems
701 Palomar Airport Rd.
Suite 300
Carlsbad,  CA  92009
Applicant Contact RANDALL HUEBNER
Correspondent
Orthopaedic Biosystems
701 Palomar Airport Rd.
Suite 300
Carlsbad,  CA  92009
Correspondent Contact RANDALL HUEBNER
Classification Product Code
LZJ  
Date Received04/08/1991
Decision Date 06/28/1991
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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