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FDA 510(k)

QUANTUM CEMENT RESTRICTOR

K-Number: K040276 · 2004-04-30

ApplicantQuantum Orthopedics
Decision Date2004-04-30
Product CodeJDK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

QUANTUM CEMENT RESTRICTOR is the device name listed in this FDA 510(k) record. The listed applicant is Quantum Orthopedics. It received FDA 510(k) clearance on 2004-04-30 under 510(k) number K040276. 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 QUANTUM CEMENT RESTRICTOR?

QUANTUM CEMENT RESTRICTOR is a medical device that received FDA 510(k) clearance on 2004-04-30. The listed applicant is Quantum Orthopedics. The 510(k) number is K040276.

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

QUANTUM CEMENT RESTRICTOR received FDA 510(k) clearance on 2004-04-30, under 510(k) number K040276.

Who is the listed applicant for QUANTUM CEMENT RESTRICTOR?

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

What is the FDA product code for QUANTUM CEMENT RESTRICTOR?

The FDA product code for QUANTUM 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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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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