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FDA 510(k)

FIDJI SMALL CEMENT RESTRICTOR

K-Number: K030767 · 2003-12-22

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

Device Summary

FIDJI SMALL 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 K030767. 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 SMALL CEMENT RESTRICTOR?

FIDJI SMALL 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 K030767.

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

FIDJI SMALL CEMENT RESTRICTOR received FDA 510(k) clearance on 2003-12-22, under 510(k) number K030767.

Who is the listed applicant for FIDJI SMALL 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 SMALL CEMENT RESTRICTOR?

The FDA product code for FIDJI SMALL 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.

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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.

K030871FIDJI LARGE 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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