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)

KNEE, TOTAL, FEMORAL & TIBIAL

K-Number: K780904 · 1978-06-22

ApplicantDepuy, Inc.
Decision Date1978-06-22
Product CodeMBV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KNEE, TOTAL, FEMORAL & TIBIAL is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1978-06-22 under 510(k) number K780904. The device is classified under product code MBV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KNEE, TOTAL, FEMORAL & TIBIAL?

KNEE, TOTAL, FEMORAL & TIBIAL is a medical device that received FDA 510(k) clearance on 1978-06-22. The listed applicant is Depuy, Inc.. The 510(k) number is K780904.

When did KNEE, TOTAL, FEMORAL & TIBIAL receive FDA 510(k) clearance?

KNEE, TOTAL, FEMORAL & TIBIAL received FDA 510(k) clearance on 1978-06-22, under 510(k) number K780904.

Who is the listed applicant for KNEE, TOTAL, FEMORAL & TIBIAL?

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 KNEE, TOTAL, FEMORAL & TIBIAL?

The FDA product code for KNEE, TOTAL, FEMORAL & TIBIAL is MBV.

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: MBV)

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.

K010212OFFSET TIBIAL TRAYBiomet, Inc.K884824TRICON-M TOTAL KNEE SYSTEMRichards Medical Co., Inc.K873429FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEEProtek, Inc.K853730FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REPProtek, Inc.K833200TRICON M TOTAL KNEE SYSTEMRichards Medical Co., Inc.K831441POROCOAT FREEMAN/SAMUELSON TOTAL KNEEDepuy, Inc.

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.

↑