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FDA 510(k) Application Details - K210893
Device Classification Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
More FDA Info for this Device
510(K) Number
K210893
Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Applicant
Howmedica Osteonics Corp. a.k.a. Stryker Orthopaedics
325 Corporate Drive
Mahwah, NJ 07430 US
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Contact
Alexandra Kirby
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Regulation Number
888.3358
More FDA Info for this Regulation Number
Classification Product Code
LPH
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More FDA Info for this Product Code
Date Received
03/25/2021
Decision Date
04/22/2021
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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