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)

EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM

K-Number: K050766 · 2005-05-26

ApplicantZimmer Trabecular
Decision Date2005-05-26
Product CodeHWE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Trabecular. It received FDA 510(k) clearance on 2005-05-26 under 510(k) number K050766. The device is classified under product code HWE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM?

EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM is a medical device that received FDA 510(k) clearance on 2005-05-26. The listed applicant is Zimmer Trabecular. The 510(k) number is K050766.

When did EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM receive FDA 510(k) clearance?

EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM received FDA 510(k) clearance on 2005-05-26, under 510(k) number K050766.

Who is the listed applicant for EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM?

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

What is the FDA product code for EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM?

The FDA product code for EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM is HWE.

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 Zimmer Trabecular 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.

K061155VISTA P VERTEBRAL BODY REPLACEMENT SYSTEMK061067TRABECULAR METAL ACETABULAR AUGMENTSK053340TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTSK052950THE ZIMMER TMT TRABECULAR METAL VERTEBRAL BODY REPLACEMENT SYSTEMK051756MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZK050937TRABECULAR METAL ACETABULAR REVISION SHELLS

View all 10 devices →

Related Devices (Code: HWE)

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.

K102743ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRESOrtho Solutions LimitedK063688SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBEThe Anspach Effort, Inc.K043310SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEMSynthes (Usa)K022744REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURSMedical Device ServicesK012694REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURSAdven MedicalK012676REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPSAdven Medical

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.

↑