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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, Constrained, Polymer
510(k) Number K981194
Device Name FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT
Applicant
Nexa Orthopedics, Inc.
9369 Carroll Park Dr., Suite A
San Diego,  CA  92121
Applicant Contact JAMAL D RUSHY
Correspondent
Nexa Orthopedics, Inc.
9369 Carroll Park Dr., Suite A
San Diego,  CA  92121
Correspondent Contact JAMAL D RUSHY
Regulation Number888.3720
Classification Product Code
KWH  
Date Received04/02/1998
Decision Date 06/30/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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