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)

LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS

K-Number: K093846 · 2010-02-04

ApplicantZimmer, Inc.
Decision Date2010-02-04
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2010-02-04 under 510(k) number K093846. 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 LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS?

LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS is a medical device that received FDA 510(k) clearance on 2010-02-04. The listed applicant is Zimmer, Inc.. The 510(k) number is K093846.

When did LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS receive FDA 510(k) clearance?

LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS received FDA 510(k) clearance on 2010-02-04, under 510(k) number K093846.

Who is the listed applicant for LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS?

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

What is the FDA product code for LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS?

The FDA product code for LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS 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 Zimmer, 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.

K262955OsseoFit Stemless Shoulder SystemK260831Z1 Hip SystemK261683Augment Off-Axis Instrument SystemK251840Zimmer® Persona® Personalized Knee SystemK260182Avenir® Müller Stem; Avenir Complete™ Hip SystemK253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)

View all 344 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.

↑