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510(k) K143126

Renovis S141 Lumbar Interbody Cage System by Renovis Surgical Technologies — Product Code MAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2015
Date Received
October 31, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

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  • 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)
  • K141676 — RENOVIS SURGICAL POROUS ACETABULAR CUP SYSTEM (November 4, 2014)

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