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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K181752
Device Name Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)
Applicant
Stryker Corporation
4100 E. Milham Avenue
Kalamazoo,  MI  49001
Applicant Contact Kristi Ashton
Correspondent
Stryker Corporation
4100 E. Milham Avenue
Kalamazoo,  MI  49001
Correspondent Contact Kristi Ashton
Regulation Number888.1100
Classification Product Code
HRX  
Subsequent Product Code
NDN  
Date Received07/02/2018
Decision Date 12/21/2018
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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