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FDA 510(k)

FORTITUDE CEMENT RESTRICTOR

K-Number: K021719 · 2002-08-15

ApplicantSpinal Concepts, Inc.
Decision Date2002-08-15
Product CodeJDK
Advisory CommitteeSU
DecisionUnknown

Device Summary

FORTITUDE CEMENT RESTRICTOR is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Concepts, Inc.. It received FDA 510(k) clearance on 2002-08-15 under 510(k) number K021719. 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 FORTITUDE CEMENT RESTRICTOR?

FORTITUDE CEMENT RESTRICTOR is a medical device that received FDA 510(k) clearance on 2002-08-15. The listed applicant is Spinal Concepts, Inc.. The 510(k) number is K021719.

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

FORTITUDE CEMENT RESTRICTOR received FDA 510(k) clearance on 2002-08-15, under 510(k) number K021719.

Who is the listed applicant for FORTITUDE CEMENT RESTRICTOR?

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

What is the FDA product code for FORTITUDE CEMENT RESTRICTOR?

The FDA product code for FORTITUDE CEMENT RESTRICTOR is JDK.

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Other records listing Spinal Concepts, Inc. 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.

K051000FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICEK050706HARMONY PORT SYSTEM, MODEL 1907 SERIESK040096SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEMK033663SPINAL CONCEPTS INC. CODAK033517SPINAL CONCEPTS INC. CADENCE AND TRAXISK031855SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEM

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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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