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FDA 510(k)

FIDJI LARGE CEMENT RESTRICTOR

K-Number: K030871 · 2003-12-22

ApplicantSpine Next SA
Decision Date2003-12-22
Product CodeJDK
Advisory CommitteeSU
DecisionUnknown

Device Summary

FIDJI LARGE CEMENT RESTRICTOR is the device name listed in this FDA 510(k) record. The listed applicant is Spine Next SA. It received FDA 510(k) clearance on 2003-12-22 under 510(k) number K030871. The device is classified under product code JDK. It was reviewed by the SU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the FIDJI LARGE CEMENT RESTRICTOR?

FIDJI LARGE CEMENT RESTRICTOR is a medical device that received FDA 510(k) clearance on 2003-12-22. The listed applicant is Spine Next SA. The 510(k) number is K030871.

When did FIDJI LARGE CEMENT RESTRICTOR receive FDA 510(k) clearance?

FIDJI LARGE CEMENT RESTRICTOR received FDA 510(k) clearance on 2003-12-22, under 510(k) number K030871.

Who is the listed applicant for FIDJI LARGE CEMENT RESTRICTOR?

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

What is the FDA product code for FIDJI LARGE CEMENT RESTRICTOR?

The FDA product code for FIDJI LARGE CEMENT 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 Spine Next SA 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.

K030767FIDJI SMALL CEMENT RESTRICTORK031265SHIRAZ-JAVA SPINAL FIXATION SYSTEM

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.

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