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FDA 510(k)

UNICOMPARTMENTAL KNEE

K-Number: K072704 · 2008-02-19

ApplicantValpo Orthopedic Technology, Inc.
Decision Date2008-02-19
Product CodeHRY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UNICOMPARTMENTAL KNEE is the device name listed in this FDA 510(k) record. The listed applicant is Valpo Orthopedic Technology, Inc.. It received FDA 510(k) clearance on 2008-02-19 under 510(k) number K072704. 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 UNICOMPARTMENTAL KNEE?

UNICOMPARTMENTAL KNEE is a medical device that received FDA 510(k) clearance on 2008-02-19. The listed applicant is Valpo Orthopedic Technology, Inc.. The 510(k) number is K072704.

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

UNICOMPARTMENTAL KNEE received FDA 510(k) clearance on 2008-02-19, under 510(k) number K072704.

Who is the listed applicant for UNICOMPARTMENTAL KNEE?

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

What is the FDA product code for UNICOMPARTMENTAL KNEE?

The FDA product code for UNICOMPARTMENTAL KNEE is HRY.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Valpo Orthopedic Technology, 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.

K062734ADJUST-RIGHT FIXATION DEVICES

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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