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FDA 510(k)

RABEA CEMENT RESTRICTOR

K-Number: K020836 · 2002-06-11

ApplicantSignus Medical, LLC
Decision Date2002-06-11
Product CodeJDK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RABEA CEMENT RESTRICTOR is the device name listed in this FDA 510(k) record. The listed applicant is Signus Medical, LLC. It received FDA 510(k) clearance on 2002-06-11 under 510(k) number K020836. 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 RABEA CEMENT RESTRICTOR?

RABEA CEMENT RESTRICTOR is a medical device that received FDA 510(k) clearance on 2002-06-11. The listed applicant is Signus Medical, LLC. The 510(k) number is K020836.

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

RABEA CEMENT RESTRICTOR received FDA 510(k) clearance on 2002-06-11, under 510(k) number K020836.

Who is the listed applicant for RABEA CEMENT RESTRICTOR?

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

What is the FDA product code for RABEA CEMENT RESTRICTOR?

The FDA product code for RABEA CEMENT RESTRICTOR is JDK.

Related Clinical Trials

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Other records listing Signus Medical, LLC 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.

K081108MONOPOLY PEDICLE SCREW SYSTEMK052096NUBIC SPINAL IMPLANTK031455CONKLUSION PEDICLE SCREW SYSTEMK031757PEEK TETRIS SPINAL IMPLANTK022793TETRIS SPINAL IMPLANT

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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