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FDA 510(k)

Expandable Titanium PLIF/TLIF System

K-Number: K253377 · 2025-10-24

ApplicantSpectrum Spine, Inc.
Decision Date2025-10-24
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Expandable Titanium PLIF/TLIF System is a medical device manufactured by Spectrum Spine, Inc.. It received FDA 510(k) clearance on 2025-10-24 under approval number K253377. 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 Expandable Titanium PLIF/TLIF System?

Expandable Titanium PLIF/TLIF System is a medical device that received FDA 510(k) clearance on 2025-10-24. It is manufactured by Spectrum Spine, Inc.. The 510(k) number is K253377.

When was Expandable Titanium PLIF/TLIF System approved by the FDA?

Expandable Titanium PLIF/TLIF System received FDA 510(k) clearance on 2025-10-24, under approval number K253377.

What company makes Expandable Titanium PLIF/TLIF System?

Expandable Titanium PLIF/TLIF System is manufactured by Spectrum Spine, Inc..

What is the FDA product code for Expandable Titanium PLIF/TLIF System?

The FDA product code for Expandable Titanium PLIF/TLIF System is MAX.

Related Clinical Trials

NCT07569575 Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures NOT_YET_RECRUITING NCT07538141 The Hyalex MTP Study RECRUITING NCT07082426 Early System Experience With the Abbott Balloon-expandable TAVI System: First-In-Human Study ACTIVE_NOT_RECRUITING

Other Devices by Spectrum Spine, Inc.

K240838Spectrum Spine Cervical Cage System K243074Spectrum Spine Lumbar Cage System

Related Devices (Code: MAX)

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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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