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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, Semi-Constrained, Metal/Polymer Cemented
510(k) Number K131277
Device Name SEVIIN FRACTURE SHOULDER
Applicant
Ingen Orthopedics, LLC
2650 Us Hwy. 130
Cranbury,  NJ  08512
Applicant Contact PERRY A GEREMAKIS
Correspondent
Ingen Orthopedics, LLC
2650 Us Hwy. 130
Cranbury,  NJ  08512
Correspondent Contact PERRY A GEREMAKIS
Regulation Number888.3660
Classification Product Code
KWS  
Subsequent Product Codes
HSD   KWT  
Date Received05/06/2013
Decision Date 08/28/2013
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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