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FDA 510(k)

OPTIMESH 500E CEMENT RESTRICTOR

K-Number: K033953 · 2004-07-06

ApplicantSpineology, Inc.
Decision Date2004-07-06
Product CodeJDK
Advisory CommitteeSU
DecisionUnknown

Device Summary

OPTIMESH 500E CEMENT RESTRICTOR is the device name listed in this FDA 510(k) record. The listed applicant is Spineology, Inc.. It received FDA 510(k) clearance on 2004-07-06 under 510(k) number K033953. 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 OPTIMESH 500E CEMENT RESTRICTOR?

OPTIMESH 500E CEMENT RESTRICTOR is a medical device that received FDA 510(k) clearance on 2004-07-06. The listed applicant is Spineology, Inc.. The 510(k) number is K033953.

When did OPTIMESH 500E CEMENT RESTRICTOR receive FDA 510(k) clearance?

OPTIMESH 500E CEMENT RESTRICTOR received FDA 510(k) clearance on 2004-07-06, under 510(k) number K033953.

Who is the listed applicant for OPTIMESH 500E CEMENT RESTRICTOR?

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

What is the FDA product code for OPTIMESH 500E CEMENT RESTRICTOR?

The FDA product code for OPTIMESH 500E CEMENT RESTRICTOR is JDK.

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Other records listing Spineology, Inc. as applicant

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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

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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