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FDA 510(k)

RBK PATELLA FEMORAL KNEE

K-Number: K050473 · 2005-11-14

ApplicantGlobal Orthopaedic Technology, USA, Inc.
Decision Date2005-11-14
Product CodeKRR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RBK PATELLA FEMORAL KNEE is the device name listed in this FDA 510(k) record. The listed applicant is Global Orthopaedic Technology, USA, Inc.. It received FDA 510(k) clearance on 2005-11-14 under 510(k) number K050473. The device is classified under product code KRR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RBK PATELLA FEMORAL KNEE?

RBK PATELLA FEMORAL KNEE is a medical device that received FDA 510(k) clearance on 2005-11-14. The listed applicant is Global Orthopaedic Technology, USA, Inc.. The 510(k) number is K050473.

When did RBK PATELLA FEMORAL KNEE receive FDA 510(k) clearance?

RBK PATELLA FEMORAL KNEE received FDA 510(k) clearance on 2005-11-14, under 510(k) number K050473.

Who is the listed applicant for RBK PATELLA FEMORAL KNEE?

The FDA 510(k) record lists Global Orthopaedic Technology, USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RBK PATELLA FEMORAL KNEE?

The FDA product code for RBK PATELLA FEMORAL KNEE is KRR.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Global Orthopaedic Technology, USA, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K051721GLOBAL RESURFACING UNICOMPARTMENTAL KNEE SYSTEMK033351GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEE

Related Devices (Code: KRR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231253Overture Orthopaedics Patellofemoral SystemOverture Resurfacing, Inc.K221048Episealer Patellofemoral SystemEpisurf Medical, Inc.K211303Avon Patello-femoral Joint ProsthesisHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK200122MOTO PFJ SystemMedacta International S.A.K181280Patello-Femoral Wave (Kahuna) Arthroplasty SystemArthrosurface, Inc.K160461Arthrex iBalance BiCompartmental Arthroplasty SystemArthrex, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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