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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Fixation Device, Spinal
510(k) Number K894184
Device Name BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEM
Applicant
Biedermann Motech GmbH
Berta-Suttner-Strasse 23
Vs-Schwenningen,  DE D-78054
Applicant Contact LUTZ BIEDERMANN
Correspondent
Biedermann Motech GmbH
Berta-Suttner-Strasse 23
Vs-Schwenningen,  DE D-78054
Correspondent Contact LUTZ BIEDERMANN
Regulation Number888.3060
Classification Product Code
JDN  
Date Received06/16/1989
Decision Date 04/25/1990
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
Predetermined Change
Control Plan Authorized		 No
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