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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
510(k) Number K950384
Device Name SYNTHES(USA) SYNTHES HYBRID EXTERNAL FIXATOR
Applicant
Synthes (Usa)
1690 Russell Rd.
Post Office Box 1766
Paoli,  PA  19301
Applicant Contact ANGELA J SILVESTRI
Correspondent
Synthes (Usa)
1690 Russell Rd.
Post Office Box 1766
Paoli,  PA  19301
Correspondent Contact ANGELA J SILVESTRI
Regulation Number888.3030
Classification Product Code
LXT  
Date Received02/01/1995
Decision Date 05/22/1995
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
Recalls CDRH Recalls
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