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510(k) K050764

UNIGLIDE UNICONDYLAR KNEE PROSTHESIS by Corin USA — Product Code HRY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 2005
Date Received
March 24, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3530
Review Panel
OR
Submission Type

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  • 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)
  • K181061 — Corin Optimized Positioning System (OPS) Femoral (September 7, 2018)
  • K152893 — Corin Optimized Positioning System (OPS) (June 3, 2016)

Other clearances for product code HRY

  • K193549 — SIGMA High Performance (HP) Partial Knee System (April 16, 2020)
  • K190633 — NanoOrtho NanoKnee® System (December 20, 2019)
  • K152631 — MPO Total Knee Systems MR Labeling (March 23, 2016)
  • K150410 — RESTORIS POROUS PARTIAL KNEE SYSTEM (March 20, 2015)
  • K133940 — OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS) (March 28, 2014)
  • K131167 — UNIVATION (October 17, 2013)
  • K122277 — OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) (October 22, 2012)
  • K110415 — SIGNATURE PLANNER / SIGNATURE GUIDES (May 16, 2011)
  • K100973 — EVOLUTION UNICONDYLAR KNEE SYSTEM (August 10, 2010)
  • K082567 — STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION (October 3, 2008)