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FDA 510(k)

GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEE

K-Number: K033351 · 2004-03-11

ApplicantGlobal Orthopaedic Technology, USA, Inc.
Decision Date2004-03-11
Product CodeHRY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) 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 2004-03-11 under 510(k) number K033351. The device is classified under product code HRY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEE?

GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEE is a medical device that received FDA 510(k) clearance on 2004-03-11. The listed applicant is Global Orthopaedic Technology, USA, Inc.. The 510(k) number is K033351.

When did GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEE receive FDA 510(k) clearance?

GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEE received FDA 510(k) clearance on 2004-03-11, under 510(k) number K033351.

Who is the listed applicant for GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) 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 GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEE?

The FDA product code for GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEE is HRY.

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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.

K050473RBK PATELLA FEMORAL KNEEK051721GLOBAL RESURFACING UNICOMPARTMENTAL KNEE SYSTEM

Related Devices (Code: HRY)

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.

K193549SIGMA High Performance (HP) Partial Knee SystemDepuy Ireland UCK190633NanoOrtho NanoKnee® SystemNanoortho, LLCK152631MPO Total Knee Systems MR LabelingMicroport Orthopedics, Inc.K131167UNIVATIONAesculap Implant Systems, LLCK122277OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEMBiomet Manufacturing CorpK110415SIGNATURE PLANNER / SIGNATURE GUIDESMaterialise NV

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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