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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 K885229
Device Name MODIFIED GLENOID ARCUATE DRILL & DISP. FLEXI-BITS
Applicant
Romano Surgical Instrumentation, Inc.
4000 Aurora Ave. N.,
Suite 112
Seattle,  WA  98103
Applicant Contact JACK W ROMANO
Correspondent
Romano Surgical Instrumentation, Inc.
4000 Aurora Ave. N.,
Suite 112
Seattle,  WA  98103
Correspondent Contact JACK W ROMANO
Regulation Number878.4820
Classification Product Code
HSZ  
Date Received12/09/1988
Decision Date 09/29/1989
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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