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FDA 510(k)

FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE

K-Number: K051000 · 2005-05-19

ApplicantSpinal Concepts, Inc.
Decision Date2005-05-19
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE 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 2005-05-19 under 510(k) number K051000. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE?

FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE is a medical device that received FDA 510(k) clearance on 2005-05-19. The listed applicant is Spinal Concepts, Inc.. The 510(k) number is K051000.

When did FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE receive FDA 510(k) clearance?

FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE received FDA 510(k) clearance on 2005-05-19, under 510(k) number K051000.

Who is the listed applicant for FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE?

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 VUE VERTEBRAL BODY REPLACEMENT DEVICE?

The FDA product code for FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE is MQP.

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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.

K050706HARMONY 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 SYSTEMK031985SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEM

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Related Devices (Code: MQP)

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.

K261810Vertiwedge® Intraosseous SystemFoundation Surgical GroupK261031POSEIDON STSignus Medinzintechnik GmbHK253158VyBrate™ VBR SystemVy Spine, LLCK241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AGK233359DOMINION Expandable Corpectomy SystemAstura Medical

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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