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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
510(k) Number K831233
Device Name GLENOID RESURFACING COMPONENT-3M-10816
Applicant
3M Company
2724 S. Peck Rd.
Monrovia,  CA  91016
Correspondent
3M Company
2724 S. Peck Rd.
Monrovia,  CA  91016
Regulation Number888.3650
Classification Product Code
KWT  
Date Received04/15/1983
Decision Date 06/03/1983
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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