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FDA 510(k)

Spectrum Spine Expandable Cages (SSEC)

K-Number: K173518 · 2019-03-07

ApplicantSpectrum Spine, LLC
Decision Date2019-03-07
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Spectrum Spine Expandable Cages (SSEC) is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Spine, LLC. It received FDA 510(k) clearance on 2019-03-07 under 510(k) number K173518. 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 Spectrum Spine Expandable Cages (SSEC)?

Spectrum Spine Expandable Cages (SSEC) is a medical device that received FDA 510(k) clearance on 2019-03-07. The listed applicant is Spectrum Spine, LLC. The 510(k) number is K173518.

When did Spectrum Spine Expandable Cages (SSEC) receive FDA 510(k) clearance?

Spectrum Spine Expandable Cages (SSEC) received FDA 510(k) clearance on 2019-03-07, under 510(k) number K173518.

Who is the listed applicant for Spectrum Spine Expandable Cages (SSEC)?

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

What is the FDA product code for Spectrum Spine Expandable Cages (SSEC)?

The FDA product code for Spectrum Spine Expandable Cages (SSEC) is MAX.

Other records listing Spectrum Spine, LLC 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.

K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemK253377Expandable Titanium PLIF/TLIF SystemK243074Spectrum Spine Lumbar Cage SystemK240838Spectrum Spine Cervical Cage SystemK201024Expandable Titanium PLIF/TLIF System

Related Devices (Code: MAX)

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.

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 CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.

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.

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