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FDA 510(k)

UNIGLIDE UNICONDYLAR KNEE PROSTHESIS

K-Number: K050764 · 2005-08-24

ApplicantCorin USA
Decision Date2005-08-24
Product CodeHRY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UNIGLIDE UNICONDYLAR KNEE PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Corin USA. It received FDA 510(k) clearance on 2005-08-24 under 510(k) number K050764. 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 UNIGLIDE UNICONDYLAR KNEE PROSTHESIS?

UNIGLIDE UNICONDYLAR KNEE PROSTHESIS is a medical device that received FDA 510(k) clearance on 2005-08-24. The listed applicant is Corin USA. The 510(k) number is K050764.

When did UNIGLIDE UNICONDYLAR KNEE PROSTHESIS receive FDA 510(k) clearance?

UNIGLIDE UNICONDYLAR KNEE PROSTHESIS received FDA 510(k) clearance on 2005-08-24, under 510(k) number K050764.

Who is the listed applicant for UNIGLIDE UNICONDYLAR KNEE PROSTHESIS?

The FDA 510(k) record lists Corin USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNIGLIDE UNICONDYLAR KNEE PROSTHESIS?

The FDA product code for UNIGLIDE UNICONDYLAR KNEE PROSTHESIS is HRY.

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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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