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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, Hemi-, Humeral, Metallic Uncemented
510(k) Number K911902
Device Name TEMPERLITE(TM) SAW BLADE
Applicant
Sierra Surgical, Inc.
11315 Sunrise Gold Cir.,
Suite L
Rancho Cordova,  CA  95742
Applicant Contact REBECCA ANDERSEN
Correspondent
Sierra Surgical, Inc.
11315 Sunrise Gold Cir.,
Suite L
Rancho Cordova,  CA  95742
Correspondent Contact REBECCA ANDERSEN
Regulation Number888.3690
Classification Product Code
HSD  
Date Received04/26/1991
Decision Date 06/28/1991
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
Recalls CDRH Recalls
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