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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, Ac-Powered Motor And Accessory/Attachment
510(k) Number K970040
Device Name SPINE-TECH BONE HARVESTER
Applicant
Spine-Tech, Inc.
7375 Bush Lake Rd.
Minneapolis,  MN  55439
Applicant Contact DAVID A CANNISTRACI
Correspondent
Spine-Tech, Inc.
7375 Bush Lake Rd.
Minneapolis,  MN  55439
Correspondent Contact DAVID A CANNISTRACI
Regulation Number878.4820
Classification Product Code
HWE  
Date Received01/06/1997
Decision Date 02/28/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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