Data / Medical devices / Orthosis, Spinal Pedicle Fixation

Orthosis, Spinal Pedicle Fixation (MNI): 294 FDA-registered makers in 19 countries

294 establishments in 19 countries are registered with the FDA to make Orthosis, Spinal Pedicle Fixation (product code MNI, Class 2, 21 CFR 888.3070). 63 of them have a 510(k) clearance or PMA approval on file and 8 have a recall event. The FDA has issued 303 510(k) clearances under this code, the latest on October 12, 2017, and lists 32 recall events (0 Class I). FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Product code

MNI

Device class

2

Regulation

888.3070

Medical specialty

Orthopedic

Implant

Yes

Makers by country

Makers of Orthosis, Spinal Pedicle Fixation

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 12, 2017. 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.