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 ANATOMIC PATELLA GROOVE (APG) / VANGUARD V GROOVE

K-Number: K061433 · 2006-08-21

ApplicantBiomet Manufacturing, Inc.
Decision Date2006-08-21
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VANGUARD ANATOMIC PATELLA GROOVE (APG) / VANGUARD V GROOVE 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 2006-08-21 under 510(k) number K061433. 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 VANGUARD ANATOMIC PATELLA GROOVE (APG) / VANGUARD V GROOVE?

VANGUARD ANATOMIC PATELLA GROOVE (APG) / VANGUARD V GROOVE is a medical device that received FDA 510(k) clearance on 2006-08-21. The listed applicant is Biomet Manufacturing, Inc.. The 510(k) number is K061433.

When did VANGUARD ANATOMIC PATELLA GROOVE (APG) / VANGUARD V GROOVE receive FDA 510(k) clearance?

VANGUARD ANATOMIC PATELLA GROOVE (APG) / VANGUARD V GROOVE received FDA 510(k) clearance on 2006-08-21, under 510(k) number K061433.

Who is the listed applicant for VANGUARD ANATOMIC PATELLA GROOVE (APG) / VANGUARD V GROOVE?

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 ANATOMIC PATELLA GROOVE (APG) / VANGUARD V GROOVE?

The FDA product code for VANGUARD ANATOMIC PATELLA GROOVE (APG) / VANGUARD V GROOVE 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 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: 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.

↑