Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ADVANCE UNICONDYLAR KNEE SYSTEM

K-Number: K014171 · 2002-03-15

ApplicantWrightmedicaltechnologyinc
Decision Date2002-03-15
Product CodeHRY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ADVANCE UNICONDYLAR KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2002-03-15 under 510(k) number K014171. 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 ADVANCE UNICONDYLAR KNEE SYSTEM?

ADVANCE UNICONDYLAR KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 2002-03-15. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K014171.

When did ADVANCE UNICONDYLAR KNEE SYSTEM receive FDA 510(k) clearance?

ADVANCE UNICONDYLAR KNEE SYSTEM received FDA 510(k) clearance on 2002-03-15, under 510(k) number K014171.

Who is the listed applicant for ADVANCE UNICONDYLAR KNEE SYSTEM?

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

What is the FDA product code for ADVANCE UNICONDYLAR KNEE SYSTEM?

The FDA product code for ADVANCE UNICONDYLAR KNEE SYSTEM 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 Wrightmedicaltechnologyinc 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.

K222835Prophecy Preoperative Navigation Alignment SystemK213342PRO-DENSE LoVisc Bone Graft SubstituteK212996Sterile PHALINX Hammertoe SystemK202815PROPHECY Preoperative Navigation Alignment SystemK201259ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemK200507PRO-DENSE LoVisc Bone Graft Substitute

View all 268 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.

↑