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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
510(k) Number K190276
Device Name Provident II Hip Stem
Applicant
Stelkast, Inc.
200 Hidden Valley Rd.
Mcmurray,  PA  15317
Applicant Contact David Stumpo
Correspondent
Musculoskeletal Clinical Regulatory Advisers, LLC
1050 K St. NW
Suite 1000
Washington,  DC  20005
Correspondent Contact Hollace Rhodes
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
JDI   KWY   LWJ   LZO   OQH  
OQI  
Date Received02/08/2019
Decision Date 03/08/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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