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FDA 510(k)

INTREPID SPINAL SYSTEM

K-Number: K080083 · 2008-04-10

ApplicantMedtronic Sofamor Danek
Decision Date2008-04-10
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INTREPID SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek. It received FDA 510(k) clearance on 2008-04-10 under 510(k) number K080083. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTREPID SPINAL SYSTEM?

INTREPID SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2008-04-10. The listed applicant is Medtronic Sofamor Danek. The 510(k) number is K080083.

When did INTREPID SPINAL SYSTEM receive FDA 510(k) clearance?

INTREPID SPINAL SYSTEM received FDA 510(k) clearance on 2008-04-10, under 510(k) number K080083.

Who is the listed applicant for INTREPID SPINAL SYSTEM?

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

What is the FDA product code for INTREPID SPINAL SYSTEM?

The FDA product code for INTREPID SPINAL SYSTEM is MAX.

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Related Devices (Code: MAX)

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K261049SCALA® TLSpineart SAK261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.

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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