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)

3DKNEE POROUS COATED FEMORAL COMPONENT

K-Number: K032905 · 2004-07-06

ApplicantEncore Orthopedics, Inc.
Decision Date2004-07-06
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

3DKNEE POROUS COATED FEMORAL COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Encore Orthopedics, Inc.. It received FDA 510(k) clearance on 2004-07-06 under 510(k) number K032905. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3DKNEE POROUS COATED FEMORAL COMPONENT?

3DKNEE POROUS COATED FEMORAL COMPONENT is a medical device that received FDA 510(k) clearance on 2004-07-06. The listed applicant is Encore Orthopedics, Inc.. The 510(k) number is K032905.

When did 3DKNEE POROUS COATED FEMORAL COMPONENT receive FDA 510(k) clearance?

3DKNEE POROUS COATED FEMORAL COMPONENT received FDA 510(k) clearance on 2004-07-06, under 510(k) number K032905.

Who is the listed applicant for 3DKNEE POROUS COATED FEMORAL COMPONENT?

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

What is the FDA product code for 3DKNEE POROUS COATED FEMORAL COMPONENT?

The FDA product code for 3DKNEE POROUS COATED FEMORAL COMPONENT is MBH.

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 Encore Orthopedics, 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.

K0201143D KNEEK020741UNICONDYLAR KNEEK020236MODIFICATION TO PASS SPINAL SYSTEMK020170KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UPK013490CEMENTED CALCAR HIP SYSTEMK013442PASS SPINAL SYSTEM

View all 85 devices →

Related Devices (Code: MBH)

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.

K261275Unity Total Knee System, Unity Knee Cementless CR FemurCorin, Ltd.K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.

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.

↑