Data / Medical devices / Thoracolumbosacral Pedicle Screw System

Thoracolumbosacral Pedicle Screw System (NKB): 357 FDA-registered makers in 19 countries

357 establishments in 19 countries are registered with the FDA to make Thoracolumbosacral Pedicle Screw System (product code NKB, Class 2, 21 CFR 888.3070). 155 of them have a 510(k) clearance or PMA approval on file and 21 have a recall event. The FDA has issued 914 510(k) clearances under this code, the latest on October 2, 2026, and lists 86 recall events (1 Class I). FDA data exported November 2, 2026.

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Product code

NKB

Device class

2

Regulation

888.3070

Medical specialty

Orthopedic

Implant

Yes

Makers by country

Makers of Thoracolumbosacral Pedicle Screw System

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Updated October 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.