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FDA 510(k) Application Details - K201733
Device Classification Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
More FDA Info for this Device
510(K) Number
K201733
Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Applicant
Globus Medical Inc.
2560 General Armistead Ave.
Audubon, PA 19403 US
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Contact
Jennifer Antonacci
Other 510(k) Applications for this Contact
Regulation Number
888.3358
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Classification Product Code
LPH
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More FDA Info for this Product Code
Date Received
06/25/2020
Decision Date
07/14/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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