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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Elbow, Hemi-, Radial, Polymer
510(k) Number K183618
Device Name Revolution Radial Head
Applicant
Ignite Orthopedics, Inc.
210 N. Buffalo St.
Warsaw,  IN  46580
Applicant Contact Russ Parrott
Correspondent
Ignite Orthopedics, Inc.
210 N. Buffalo St.
Warsaw,  IN  46580
Correspondent Contact Russ Parrott
Regulation Number888.3170
Classification Product Code
KWI  
Date Received12/26/2018
Decision Date 05/17/2019
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
Recalls CDRH Recalls
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