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)

RPX TITANIUM CEMNT RESTRICTOR

K-Number: K020344 · 2002-05-02

ApplicantSulzer Spine-Tech
Decision Date2002-05-02
Product CodeJDK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RPX TITANIUM CEMNT RESTRICTOR is the device name listed in this FDA 510(k) record. The listed applicant is Sulzer Spine-Tech. It received FDA 510(k) clearance on 2002-05-02 under 510(k) number K020344. The device is classified under product code JDK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RPX TITANIUM CEMNT RESTRICTOR?

RPX TITANIUM CEMNT RESTRICTOR is a medical device that received FDA 510(k) clearance on 2002-05-02. The listed applicant is Sulzer Spine-Tech. The 510(k) number is K020344.

When did RPX TITANIUM CEMNT RESTRICTOR receive FDA 510(k) clearance?

RPX TITANIUM CEMNT RESTRICTOR received FDA 510(k) clearance on 2002-05-02, under 510(k) number K020344.

Who is the listed applicant for RPX TITANIUM CEMNT RESTRICTOR?

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

What is the FDA product code for RPX TITANIUM CEMNT RESTRICTOR?

The FDA product code for RPX TITANIUM CEMNT RESTRICTOR is JDK.

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 Sulzer Spine-Tech 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.

K022374CADENCE SPINAL FIXATION SYSTEMK020196MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEMK012173DEVICE MODIFICATION OF SILHOUETTE SPINDAL FIXATION SYSTEMK012305MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEMK993067SILHOUETTE SPINAL FIXATION SYSTEMK992276MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM

View all 7 devices →

Related Devices (Code: JDK)

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.

K210062Mectaplug PE IIMedacta International S.A.K061465KMI CEMENT RESTRICTOR IMPLANTKinetikos Medical, Inc.K061698MODIFICATION TO LIFE SPINE CEMENT RESTRICTORLife SpineK060247LIFE SPINE CEMENT RESTRICTORLife SpineK060132SPINAL USA CEMENT RESTRICTOR SYSTEMSpinal USAK051371INTERBODY INNOVATIONS CEMENT RESTRICTORInterbody Innovations, Llp

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.

↑