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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
510(k) Number K241873
Device Name OsseoFit Stemless Shoulder System
Applicant
Zimmer, Inc.
1800 W. Center St.
Warsaw,  IN  46850
Applicant Contact Alexandria Irwin
Correspondent
Zimmer, Inc.
1800 W. Center St.
Warsaw,  IN  46850
Correspondent Contact Alexandria Irwin
Regulation Number888.3660
Classification Product Code
PKC  
Date Received06/27/2024
Decision Date 12/11/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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