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510(k) K201701

R3 HA Coated Acetabular Shells by Smith & Nephew, Inc. — Product Code MBL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 2020
Date Received
June 22, 2020
Clearance Type
Traditional
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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Other clearances for product code MBL

  • K201157 — Prime BIOFOAM® Multi-Hole Shells (August 24, 2021)
  • K182535 — R3 Anteverted Liners (November 19, 2018)
  • K161233 — OXINIUM DH Fermoral Heads (December 14, 2016)
  • K122382 — DYNASTY BIOFOAM SHELL (October 22, 2012)
  • K113848 — R3 XLPE LINERS (April 27, 2012)
  • K102370 — R3 XLPE ANTEVERTED LINERS (January 19, 2011)
  • 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)