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)

BIOMET PHOENIX ANKLE NAIL SYSTEM

K-Number: K081243 · 2008-06-27

ApplicantBiomet Trauma
Decision Date2008-06-27
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOMET PHOENIX ANKLE NAIL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Trauma. It received FDA 510(k) clearance on 2008-06-27 under 510(k) number K081243. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOMET PHOENIX ANKLE NAIL SYSTEM?

BIOMET PHOENIX ANKLE NAIL SYSTEM is a medical device that received FDA 510(k) clearance on 2008-06-27. The listed applicant is Biomet Trauma. The 510(k) number is K081243.

When did BIOMET PHOENIX ANKLE NAIL SYSTEM receive FDA 510(k) clearance?

BIOMET PHOENIX ANKLE NAIL SYSTEM received FDA 510(k) clearance on 2008-06-27, under 510(k) number K081243.

Who is the listed applicant for BIOMET PHOENIX ANKLE NAIL SYSTEM?

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

What is the FDA product code for BIOMET PHOENIX ANKLE NAIL SYSTEM?

The FDA product code for BIOMET PHOENIX ANKLE NAIL SYSTEM is HSB.

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 Trauma 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.

K091976BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAILK092078OPTILOCK PERIARTICULAR PLATINGK082874BIODRIVE CANNULATED SCREW SYSTEMK081244LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONSK071325BIOMET VARIABLE LOCKING PLATE SYSTEMK070823GROWTH CONTROL PLATING SYSTEM

View all 7 devices →

Related Devices (Code: HSB)

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.

K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.K261481Pangea Femur Reconstruction SystemStryker GmbHK253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized OrthopedicsK253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices 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.

↑