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 COMPRESSION HIP/SUPRACONDYLAR SCREW (CHS) SYSTEM

K-Number: K962846 · 1996-10-23

ApplicantBiodynamic Technologies, Inc.
Decision Date1996-10-23
Product CodeLXT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EZ-FIX COMPRESSION HIP/SUPRACONDYLAR SCREW (CHS) 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 1996-10-23 under 510(k) number K962846. The device is classified under product code LXT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EZ-FIX COMPRESSION HIP/SUPRACONDYLAR SCREW (CHS) SYSTEM?

EZ-FIX COMPRESSION HIP/SUPRACONDYLAR SCREW (CHS) SYSTEM is a medical device that received FDA 510(k) clearance on 1996-10-23. The listed applicant is Biodynamic Technologies, Inc.. The 510(k) number is K962846.

When did EZ-FIX COMPRESSION HIP/SUPRACONDYLAR SCREW (CHS) SYSTEM receive FDA 510(k) clearance?

EZ-FIX COMPRESSION HIP/SUPRACONDYLAR SCREW (CHS) SYSTEM received FDA 510(k) clearance on 1996-10-23, under 510(k) number K962846.

Who is the listed applicant for EZ-FIX COMPRESSION HIP/SUPRACONDYLAR SCREW (CHS) 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 COMPRESSION HIP/SUPRACONDYLAR SCREW (CHS) SYSTEM?

The FDA product code for EZ-FIX COMPRESSION HIP/SUPRACONDYLAR SCREW (CHS) SYSTEM is LXT.

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: LXT)

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.

K230067Para-Fix External Fixation SystemNew Paradigm BiomedicalK131636POLARUS CONNECTAcumed, LLCK132704DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROWBiometK112345DISTAL VOLAR RADIUS PLATING SYSTEMSMedos International SARLK090374STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(SDePuy Orthopaedics, Inc.K073135SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONSSynthes (Usa)

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.

↑