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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Guide, Drill, Ligament
510(k) Number K930573
Device Name SYNVASIVE CERAMIC SUTTING BLOCK
Applicant
Synvasive Technology, Inc.
11328 Sunrise Gold Cir.
Rancho Cordova,  CA  95742
Applicant Contact KEITH L MULLOWNEY
Correspondent
Synvasive Technology, Inc.
11328 Sunrise Gold Cir.
Rancho Cordova,  CA  95742
Correspondent Contact KEITH L MULLOWNEY
Regulation Number878.4820
Classification Product Code
LXI  
Date Received02/04/1993
Decision Date 04/07/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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