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510(k) K182007

Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System by Renovis Surgical Technologies — Product Code OVD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2018
Date Received
July 27, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

Other clearances by Renovis Surgical Technologies

  • K190122 — Renovis A200 PS Knee System as part of the Renovis A200 Knee System (June 20, 2019)
  • 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)
  • K141676 — RENOVIS SURGICAL POROUS ACETABULAR CUP SYSTEM (November 4, 2014)

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