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Spira Open Matrix LLIF

FDA 510(k)

Class II (US FDA 510(k))

510(k) K180724

by Camber Spine Technologies, Llc

Identifiers

510(k) Number
K180724 FDA 510(k)
FDA Product Code
MAX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3080 FDA 510(k)
Regulation Number
888.3080 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The SPIRA Open Matrix LLIF is an interbody fusion implant consisting of spiral support arches and Surface by Design technology. It contains up to approximately 80% porosity and is structurally similar to trabecular bone, allowing new bone to form through the cage and attach to its surfaces.

This device is supplied as a single-use implant and is intended for use in spinal fusion procedures. It is available in various sizes and models as specified by the manufacturer. The SPIRA Open Matrix LLIF has received FDA 510(k) clearance with the product code MAX and is classified under the orthopedic advisory committee.

Frequently asked questions

What is the SPIRA Open Matrix LLIF implant used for?

The SPIRA Open Matrix LLIF is an interbody fusion implant designed for spinal fusion procedures. Its spiral support arches and Surface by Design technology provide structural support while allowing new bone to form through the cage and attach to its surfaces.

Is the SPIRA Open Matrix LLIF a single-use or reusable implant?

The SPIRA Open Matrix LLIF is supplied as a single-use implant, meaning it should only be used for one patient and one procedure. It is not designed to be sterilized and reused for subsequent patients.

What sizes and models are available for the SPIRA Open Matrix LLIF?

The SPIRA Open Matrix LLIF is available in various sizes and models as specified by the manufacturer. The specific dimensions and options would be detailed in the product catalog or provided by Camber Spine Technologies, LLC upon request.

What is the regulatory status of the SPIRA Open Matrix LLIF?

The SPIRA Open Matrix LLIF has received FDA 510(k) clearance with the product code MAX and is classified under the orthopedic advisory committee. This indicates it has been determined to be substantially equivalent to predicate devices on the market.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SPIRA Technology — Camber Spine Med Tech, SPIRA™-L Open Matrix LLIF - SPINEMarketGroup, Spira Open Matrix

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Camber Spine Technologies, Llc

Sources (1)

  • FDA 510(k) K180724 24 fields · synced Sep 24, 2026