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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, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
510(k) Number K220731
Device Name Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem
Applicant
Stryker
325 Corporate Dr.
Malwah,  NJ  07430
Applicant Contact Gregg Ritter
Correspondent
Stryker
325 Corporate Dr.
Malwah,  NJ  07430
Correspondent Contact Gregg Ritter
Regulation Number888.3353
Classification Product Code
MEH  
Subsequent Product Codes
JDI   KWL   KWY   KWZ   LPH  
LWJ   LZO   MAY   MBL  
Date Received03/14/2022
Decision Date 08/11/2022
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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