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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K862157
Device Name OMC ORTHOMET CANNULATED SCREW
Applicant
Orthomet, Inc.
6301 Cecilia Cir.
Minneapolis,  MN  55439
Applicant Contact PRO TEM
Correspondent
Orthomet, Inc.
6301 Cecilia Cir.
Minneapolis,  MN  55439
Correspondent Contact PRO TEM
Date Received06/05/1986
Decision Date 08/29/1986
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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