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510(k) K190633

NanoOrtho NanoKnee® System by Nanoortho, LLC — Product Code HRY

K190633 is an FDA 510(k) premarket notification submitted by Nanoortho, LLC for the device "NanoOrtho NanoKnee® System". The FDA issued a decision of Substantially Equivalent on December 20, 2019. The device falls under product code HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3530.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2019
Date Received
March 12, 2019
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

Other clearances for product code HRY

  • K193549 — SIGMA High Performance (HP) Partial Knee System (April 16, 2020)
  • 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)
  • K081293 — UNIVATION UNICONDYLAR KNEE SYSTEM (September 22, 2008)

FDA data resources