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510(k) K242833

Legend® Acetabular Shell by Ortho Development Corp. — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2024
Date Received
September 19, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device Class
Class II
Regulation Number
888.3358
Review Panel
OR
Submission Type

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