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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 a medical device manufactured by Spectrum Spine, LLC. It received FDA 510(k) clearance on 2019-03-07 under approval 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. It is manufactured by Spectrum Spine, LLC. The 510(k) number is K173518.

When was Spectrum Spine Expandable Cages (SSEC) approved by the FDA?

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

What company makes Spectrum Spine Expandable Cages (SSEC)?

Spectrum Spine Expandable Cages (SSEC) is manufactured by Spectrum Spine, LLC.

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

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

Related Clinical Trials

NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

Other Devices by Spectrum Spine, LLC

K201024Expandable Titanium PLIF/TLIF System

Related Devices (Code: MAX)

K163180Hubble IIOrbbo Surgical, LLC K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc. K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™)Choicespine, LP K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.

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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