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510(k) K050473

RBK PATELLA FEMORAL KNEE by Global Orthopaedic Technology, USA, Inc. — Product Code KRR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2005
Date Received
February 24, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3540
Review Panel
OR
Submission Type

Other clearances by Global Orthopaedic Technology, USA, Inc.

  • K051721 — GLOBAL RESURFACING UNICOMPARTMENTAL KNEE SYSTEM (October 26, 2005)
  • K033351 — GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEE (March 11, 2004)

Other clearances for product code KRR

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  • K221048 — Episealer Patellofemoral System (December 23, 2022)
  • K211303 — Avon Patello-femoral Joint Prosthesis (June 4, 2021)
  • K200122 — MOTO PFJ System (April 20, 2020)
  • K181280 — Patello-Femoral Wave (Kahuna) Arthroplasty System (June 14, 2018)
  • K160461 — Arthrex iBalance BiCompartmental Arthroplasty System (April 12, 2016)
  • K143543 — Prelude PF Patellae (January 30, 2015)
  • K123907 — PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST (September 3, 2013)
  • K111970 — KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT (February 23, 2012)
  • K082088 — MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM II (October 22, 2008)