FDA 510(k)

OPTICAGE INTERBODY FUSION DEVICE, MODEL 9080-00

K-Number: K132479 · 2013-09-19

Decision Date2013-09-19

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

OPTICAGE INTERBODY FUSION DEVICE, MODEL 9080-00 is the device name listed in this FDA 510(k) record. The listed applicant is Interventional Spine, Inc.. It received FDA 510(k) clearance on 2013-09-19 under 510(k) number K132479. 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 OPTICAGE INTERBODY FUSION DEVICE, MODEL 9080-00?

OPTICAGE INTERBODY FUSION DEVICE, MODEL 9080-00 is a medical device that received FDA 510(k) clearance on 2013-09-19. The listed applicant is Interventional Spine, Inc.. The 510(k) number is K132479.

When did OPTICAGE INTERBODY FUSION DEVICE, MODEL 9080-00 receive FDA 510(k) clearance?

OPTICAGE INTERBODY FUSION DEVICE, MODEL 9080-00 received FDA 510(k) clearance on 2013-09-19, under 510(k) number K132479.

Who is the listed applicant for OPTICAGE INTERBODY FUSION DEVICE, MODEL 9080-00?

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

What is the FDA product code for OPTICAGE INTERBODY FUSION DEVICE, MODEL 9080-00?

The FDA product code for OPTICAGE INTERBODY FUSION DEVICE, MODEL 9080-00 is MAX.

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Other records listing Interventional Spine, Inc. as applicant

K160464Opticage(R) Expandable Interbody Fusion Device K113527OPTICAGE INTERBODY FUSION DEVICE K090767PERPOS FCD-2 SYSTEM (SINGLE PATIENT USE), ANCHOR, STABILIZER K082795SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT

Related Devices (Code: MAX)

K261049SCALA® TLSpineart SA K261430TruLift 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 Corporation K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.

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.