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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Threaded
510(k) Number K950009
Device Name POWERGRIP(TM) COMPRESSION FIXATION DEVICE
Applicant
Synvasive Technology, Inc.
11328 Sunrise Gold Cir.
Rancho Cordova,  CA  95742
Applicant Contact GARY A SEEGER
Correspondent
Synvasive Technology, Inc.
11328 Sunrise Gold Cir.
Rancho Cordova,  CA  95742
Correspondent Contact GARY A SEEGER
Regulation Number888.3040
Classification Product Code
JDW  
Date Received01/03/1995
Decision Date 08/18/1995
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
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