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510(k) K023085

RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM by Biomet Orthopedics, Inc. — Product Code JDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2002
Date Received
September 17, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device Class
Class II
Regulation Number
888.3350
Review Panel
OR
Submission Type

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