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Spira Posterior Lumbar Spacers

FDA 510(k)

Class II (US FDA 510(k))

510(k) K230942

by Camber Spine Technologies

Identifiers

510(k) Number
K230942 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 Posterior Lumbar Spacers are interbody fusion devices designed for spinal stabilization in the posterior lumbar region. These spacers feature an open matrix architecture to facilitate bone graft integration and promote bony ongrowth, aiding in the fusion process of the lumbosacral spine. Their porous structure mimics trabecular bone, enhancing osseointegration and structural stability.

Supplied as single-use devices, these spacers are intended for surgical use in controlled environments such as operating rooms. They include a rotating pin for articulation, accommodating various surgical approaches. Regulated under FDA 510(k) clearance (K230942), the devices are manufactured by Camber Spine Technologies and adhere to traditional review standards for orthopedic implants. Sterility and packaging details are not specified in the provided data.

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-A — Camber Spine Med Tech, SPIRA® Posterior Lumbar Spacers (K230942) — FDA 510 (k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Camber Spine Technologies

Sources (1)

  • FDA 510(k) K230942 24 fields · synced Sep 19, 2026