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510(k) K141370

RENOVIS CEMENTED HIP SYSTEM by Renovis Surgical Technologies, Inc. — Product Code JDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2014
Date Received
May 27, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device Class
Class II
Regulation Number
888.3350
Review Panel
OR
Submission Type

Other clearances by Renovis Surgical Technologies, Inc.

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  • K182007 — Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System (December 7, 2018)
  • K181655 — Renovis S180 Lateral Lumbar Interbody Fusion System (September 11, 2018)
  • K180502 — S128 Anterior Lumbar Interbody Fusion (ALIF) System (June 14, 2018)
  • K171543 — Renovis Surgical Hip Replacement System (November 16, 2017)
  • K170888 — Renovis S141 Lumbar Interbody Fusion System (August 8, 2017)
  • K153250 — Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System (March 16, 2016)
  • K152193 — Renovis Anterior Cervical Plate System (September 25, 2015)
  • K143647 — Renovis Surgical Hip Replacement System (May 11, 2015)
  • K143126 — Renovis S141 Lumbar Interbody Cage System (February 6, 2015)

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