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510(k) K132312

RENOVIS TESERA TRABECULAR TECHNOLOGY (T3) ACETABULAR SHELL SYSTEM by Renovis Surgical Technologies, LLC — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2014
Date Received
July 25, 2013
Clearance Type
Traditional
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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  • K143647 — Renovis Surgical Hip Replacement System (May 11, 2015)
  • K143126 — Renovis S141 Lumbar Interbody Cage System (February 6, 2015)

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