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Perla TL Posterior Osteosynthesis System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K193396

by Spineart

Identifiers

510(k) Number
K193396 FDA 510(k)
FDA Product Code
NKB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3070 FDA 510(k)
Regulation Number
888.3070 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Perla TL Posterior Osteosynthesis System is an orthopedic device used for posterior osteosynthesis. It is designed to provide stabilization and support for the spine.

The system is supplied by Spineart and is available with FDA 510K authorization. It is classified under product code NKB and has been reviewed by the Orthopedic advisory committee. The device is intended for use in a clinical setting and should be stored according to the manufacturer's instructions.

Frequently asked questions

What is the Perla TL system used for?

The Perla TL system is used for posterior osteosynthesis, providing stabilization and support for the spine in a clinical setting.

How is the Perla TL system supplied?

The system is supplied by Spineart, and its storage and handling should follow the manufacturer's instructions.

What regulatory authorization does the Perla TL system have?

The Perla TL system has FDA 510K authorization, indicating it is substantially equivalent to a predicate device.

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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Spineart

Sources (1)

  • FDA 510(k) K193396 24 fields · synced Sep 23, 2026