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510(k) K131354

RENOVIS BIPOLAR HIP SYSTEM by Renovis Surgical Technologies, LLC — Product Code KWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2013
Date Received
May 10, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Device Class
Class II
Regulation Number
888.3390
Review Panel
OR
Submission Type

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  • 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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