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FDA 510(k)

Pedimax II - Pedicular Screw Spinal System

K-Number: K180626 · 2019-02-01

ApplicantGm Dos Reis Industria E Comerico Ltda.
Decision Date2019-02-01
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Pedimax II - Pedicular Screw Spinal System is a medical device manufactured by Gm Dos Reis Industria E Comerico Ltda.. It received FDA 510(k) clearance on 2019-02-01 under approval number K180626. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pedimax II - Pedicular Screw Spinal System?

Pedimax II - Pedicular Screw Spinal System is a medical device that received FDA 510(k) clearance on 2019-02-01. It is manufactured by Gm Dos Reis Industria E Comerico Ltda.. The 510(k) number is K180626.

When was Pedimax II - Pedicular Screw Spinal System approved by the FDA?

Pedimax II - Pedicular Screw Spinal System received FDA 510(k) clearance on 2019-02-01, under approval number K180626.

What company makes Pedimax II - Pedicular Screw Spinal System?

Pedimax II - Pedicular Screw Spinal System is manufactured by Gm Dos Reis Industria E Comerico Ltda..

What is the FDA product code for Pedimax II - Pedicular Screw Spinal System?

The FDA product code for Pedimax II - Pedicular Screw Spinal System is NKB.

Related Clinical Trials

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Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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