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510(k) K061253

REFLECTION 3 ACETABULAR SYSTEM by Smith & Nephew, Inc. — Product Code MBL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 2006
Date Received
May 4, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K102370 — R3 XLPE ANTEVERTED LINERS (January 19, 2011)
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