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510(k) K183618

Revolution Radial Head by Ignite Orthopedics, Inc. — Product Code KWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2019
Date Received
December 26, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Elbow, Hemi-, Radial, Polymer
Device Class
Class II
Regulation Number
888.3170
Review Panel
OR
Submission Type

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