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510(k) K170888

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2017
Date Received
March 27, 2017
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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  • 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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