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)

TOWNLEY UNICONDYLAR KNEE

K-Number: K812012 · 1981-09-24

ApplicantDepuy, Inc.
Decision Date1981-09-24
Product CodeHRY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TOWNLEY UNICONDYLAR KNEE is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1981-09-24 under 510(k) number K812012. 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 TOWNLEY UNICONDYLAR KNEE?

TOWNLEY UNICONDYLAR KNEE is a medical device that received FDA 510(k) clearance on 1981-09-24. The listed applicant is Depuy, Inc.. The 510(k) number is K812012.

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

TOWNLEY UNICONDYLAR KNEE received FDA 510(k) clearance on 1981-09-24, under 510(k) number K812012.

Who is the listed applicant for TOWNLEY UNICONDYLAR KNEE?

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

What is the FDA product code for TOWNLEY UNICONDYLAR KNEE?

The FDA product code for TOWNLEY UNICONDYLAR 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 Depuy, 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.

K043058PINNACLE CONSTRAINED ACETABULAR LINERSK042664LPS UPPER EXTREMITYK041085LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARYK033959LPSK040544DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062K021478DELTA SHOULDER

View all 303 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.

↑