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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 K926547
Device Name MEDNEXT 1000 BONE DISSECTING SYSTEM
Applicant
Mednext, Inc.
3878 Prospect Ave., Suite 24
West Point Beach,  FL  33404
Applicant Contact THOMAS J MICKEL
Correspondent
Mednext, Inc.
3878 Prospect Ave., Suite 24
West Point Beach,  FL  33404
Correspondent Contact THOMAS J MICKEL
Regulation Number878.4820
Classification Product Code
HSZ  
Date Received12/31/1992
Decision Date 07/22/1993
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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