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510(k) K182535

R3 Anteverted Liners by Smith & Nephew, Inc. — Product Code MBL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2018
Date Received
September 14, 2018
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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  • K070756 — SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM (June 6, 2007)
  • K061253 — REFLECTION 3 ACETABULAR SYSTEM (May 31, 2006)