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)

QUATRO M FEMORAL COMPONENT

K-Number: K033313 · 2004-07-28

ApplicantWhiteside Biomechanics, Inc.
Decision Date2004-07-28
Product CodeLWJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

QUATRO M FEMORAL COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Whiteside Biomechanics, Inc.. It received FDA 510(k) clearance on 2004-07-28 under 510(k) number K033313. The device is classified under product code LWJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUATRO M FEMORAL COMPONENT?

QUATRO M FEMORAL COMPONENT is a medical device that received FDA 510(k) clearance on 2004-07-28. The listed applicant is Whiteside Biomechanics, Inc.. The 510(k) number is K033313.

When did QUATRO M FEMORAL COMPONENT receive FDA 510(k) clearance?

QUATRO M FEMORAL COMPONENT received FDA 510(k) clearance on 2004-07-28, under 510(k) number K033313.

Who is the listed applicant for QUATRO M FEMORAL COMPONENT?

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

What is the FDA product code for QUATRO M FEMORAL COMPONENT?

The FDA product code for QUATRO M FEMORAL COMPONENT is LWJ.

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 Whiteside Biomechanics, 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.

K012800SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEMK003618WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL BIO-1-1014K993903WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013K991678WHITESIDE BIOMECHANICS SPINAL SYSTEMK981238BIPOLAR FEMORAL HEADK973261WHITESIDE BIOMECHANICS, INC. CERAMIC UNIPOLAR FEMORAL HEAD

View all 13 devices →

Related Devices (Code: LWJ)

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.

K120595UNISYN PLUS HIP STEMConsensus Orthopedics, Inc.K103518TRINITY ACETABULAR SYSTEMCorin USAK090764NOVATION CFS PRESS-FIT AND CEMENTED STEMSExactech, Inc.K082146METHA SHORT STEM HIP SYSTEM XL FEMORAL HEADAesculap Implant Systems, Inc.K07006136MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERTHayes Medical, Inc.K062978U2 HIP STEM, TI PLASMA SPRAYUnited Orthopedic Corp.

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.

↑