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)

EZ-FIX MIDSHAFT HUMERAL INTRAMEDULLARY ROD SYSTEM

K-Number: K962553 · 1996-08-28

ApplicantBiodynamic Technologies, Inc.
Decision Date1996-08-28
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EZ-FIX MIDSHAFT HUMERAL INTRAMEDULLARY ROD SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biodynamic Technologies, Inc.. It received FDA 510(k) clearance on 1996-08-28 under 510(k) number K962553. 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 EZ-FIX MIDSHAFT HUMERAL INTRAMEDULLARY ROD SYSTEM?

EZ-FIX MIDSHAFT HUMERAL INTRAMEDULLARY ROD SYSTEM is a medical device that received FDA 510(k) clearance on 1996-08-28. The listed applicant is Biodynamic Technologies, Inc.. The 510(k) number is K962553.

When did EZ-FIX MIDSHAFT HUMERAL INTRAMEDULLARY ROD SYSTEM receive FDA 510(k) clearance?

EZ-FIX MIDSHAFT HUMERAL INTRAMEDULLARY ROD SYSTEM received FDA 510(k) clearance on 1996-08-28, under 510(k) number K962553.

Who is the listed applicant for EZ-FIX MIDSHAFT HUMERAL INTRAMEDULLARY ROD SYSTEM?

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

What is the FDA product code for EZ-FIX MIDSHAFT HUMERAL INTRAMEDULLARY ROD SYSTEM?

The FDA product code for EZ-FIX MIDSHAFT HUMERAL INTRAMEDULLARY ROD 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 Biodynamic Technologies, 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.

K990436ULTIMAX TROCHANTERIC INTRAMEDULLARY ROD SYSTEMK990481ULTIMAX DISTAL RADIAL (VOLAR) LOCKING PLATE SYSTEMK990513ULTIMAX CORTICAL BONE SCREWSK981230ULTIMAX DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEMK980102BTI HUMERAL INTRAMEDULLARY ROD SYSTEMK974756BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS

View all 30 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.

↑