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)

PROFEMUR XM DISTAL CENTRALIZER

K-Number: K130167 · 2013-04-19

ApplicantWrightmedicaltechnologyinc
Decision Date2013-04-19
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PROFEMUR XM DISTAL CENTRALIZER is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2013-04-19 under 510(k) number K130167. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROFEMUR XM DISTAL CENTRALIZER?

PROFEMUR XM DISTAL CENTRALIZER is a medical device that received FDA 510(k) clearance on 2013-04-19. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K130167.

When did PROFEMUR XM DISTAL CENTRALIZER receive FDA 510(k) clearance?

PROFEMUR XM DISTAL CENTRALIZER received FDA 510(k) clearance on 2013-04-19, under 510(k) number K130167.

Who is the listed applicant for PROFEMUR XM DISTAL CENTRALIZER?

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

What is the FDA product code for PROFEMUR XM DISTAL CENTRALIZER?

The FDA product code for PROFEMUR XM DISTAL CENTRALIZER is LZO.

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 Wrightmedicaltechnologyinc 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.

K222835Prophecy Preoperative Navigation Alignment SystemK213342PRO-DENSE LoVisc Bone Graft SubstituteK212996Sterile PHALINX Hammertoe SystemK202815PROPHECY Preoperative Navigation Alignment SystemK201259ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemK200507PRO-DENSE LoVisc Bone Graft Substitute

View all 268 devices →

Related Devices (Code: LZO)

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.

K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.K253948Momentum Acetabular Cup SystemUnited Orthopedic CorporationK261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KGK260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast GmbH

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.

↑