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510(k) K102370

R3 XLPE ANTEVERTED LINERS by Smith & Nephew, Inc. — Product Code MBL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2011
Date Received
August 20, 2010
Clearance Type
Abbreviated
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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  • K161233 — OXINIUM DH Fermoral Heads (December 14, 2016)
  • K122382 — DYNASTY BIOFOAM SHELL (October 22, 2012)
  • K113848 — R3 XLPE LINERS (April 27, 2012)
  • K093363 — COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS (January 26, 2010)
  • K092386 — R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS (November 3, 2009)
  • K070756 — SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM (June 6, 2007)
  • K061253 — REFLECTION 3 ACETABULAR SYSTEM (May 31, 2006)