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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
510(k) Number K934336
Device Name SPINALPLANE
Applicant
Synvasive Technology, Inc.
11328 Sunrise Gold Cir.
Rancho Cordova,  CA  95742
Applicant Contact CAROL LAUFENBERG
Correspondent
Synvasive Technology, Inc.
11328 Sunrise Gold Cir.
Rancho Cordova,  CA  95742
Correspondent Contact CAROL LAUFENBERG
Regulation Number878.4820
Classification Product Code
HSZ  
Date Received09/07/1993
Decision Date 03/10/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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