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)

VANGUARD PATELLA COMPONENTS

K-Number: K040770 · 2004-04-22

ApplicantBiomet Manufacturing, Inc.
Decision Date2004-04-22
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VANGUARD PATELLA COMPONENTS is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing, Inc.. It received FDA 510(k) clearance on 2004-04-22 under 510(k) number K040770. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VANGUARD PATELLA COMPONENTS?

VANGUARD PATELLA COMPONENTS is a medical device that received FDA 510(k) clearance on 2004-04-22. The listed applicant is Biomet Manufacturing, Inc.. The 510(k) number is K040770.

When did VANGUARD PATELLA COMPONENTS receive FDA 510(k) clearance?

VANGUARD PATELLA COMPONENTS received FDA 510(k) clearance on 2004-04-22, under 510(k) number K040770.

Who is the listed applicant for VANGUARD PATELLA COMPONENTS?

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

What is the FDA product code for VANGUARD PATELLA COMPONENTS?

The FDA product code for VANGUARD PATELLA COMPONENTS is JWH.

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 Biomet Manufacturing, 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.

K130390COMPREHENSIVE CONVERTIBLE GLENOIDK113271METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONSK113121COMPREHENSIVE REVERSE SHOULDERK080685HIPLOC COMPRESSION HIP SCREWK080088BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTSK071271BIOMET CABLE SYSTEM

View all 32 devices →

Related Devices (Code: JWH)

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.

K262057GMK ExtensionMedacta International SAK260063GSPE SpacerThe General Hospital Corporation, d/b/a MassachusettsK262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

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.

↑