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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K931155
Device Name STAPLE, FIXATION BONE; SCREW FIXATION BONE
Applicant
Roseburg SA
1054 31st St., NW
Suite 120 Canal Sq.
Washington,  DC  20007
Applicant Contact ISABELLE FLOCCIA
Correspondent
Roseburg SA
1054 31st St., NW
Suite 120 Canal Sq.
Washington,  DC  20007
Correspondent Contact ISABELLE FLOCCIA
Regulation Number888.3040
Classification Product Code
HWC  
Date Received03/09/1993
Decision Date 09/01/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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