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510(k) K181061

Corin Optimized Positioning System (OPS) Femoral by Corin USA — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 2018
Date Received
April 23, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type

Other clearances by Corin USA

  • K203751 — OMNIVision system (April 12, 2021)
  • K202805 — Optimized Positioning System (OPS) Insight (November 20, 2020)
  • K193545 — Corin Optimized Positioning System (OPS) Femoral (August 4, 2020)
  • K193042 — Optimized Positioning System (OPS) ReView (June 26, 2020)
  • K192656 — Optimized Positioning System (OPS) Insight (May 1, 2020)
  • K190143 — LARS AC Band Device (November 4, 2019)
  • K190834 — Corin Optimized Position System Functional Hip Analysis (OPS FHA) (July 22, 2019)
  • K183038 — Corin Optimized Positioning System (OPS) Plan (November 26, 2018)
  • K152893 — Corin Optimized Positioning System (OPS) (June 3, 2016)
  • K152903 — REVIVAL(TM) Modular Revision Hip Stem (April 29, 2016)

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