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FDA 510(k) Application Details - K203108
Device Classification Name
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510(K) Number
K203108
Device Name
Ignite Stemless Anatomic Shoulder System
Applicant
Ignite Orthopedics LLC
700 Park Avenue Suite F
Winona Lake, IN 46590 US
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Contact
Matt Purdy
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Regulation Number
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Classification Product Code
PKC
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Date Received
10/15/2020
Decision Date
07/16/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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