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FDA 510(k) Application Details - K203588
Device Classification Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
More FDA Info for this Device
510(K) Number
K203588
Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Applicant
Onkos Surgical
77 East Halsey Rd
Parsippany, NJ 07054 US
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Contact
Matthew Vernak
Other 510(k) Applications for this Contact
Regulation Number
888.3350
More FDA Info for this Regulation Number
Classification Product Code
JDI
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More FDA Info for this Product Code
Date Received
12/08/2020
Decision Date
02/05/2021
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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