Pedimax II - Pedicular Screw Spinal System— 510(k) K180626

Substantially Equivalent

Gm Dos Reis Industria E Comerico Ltda.

FDA 510(k) clearance K180626 for Pedimax II - Pedicular Screw Spinal System, Substantially Equivalent on 2019-02-01. Applicant: Gm Dos Reis Industria E Comerico Ltda..

Clearance details

Applicant: Gm Dos Reis Industria E Comerico Ltda.
Product code: Code NKB
Advisory panel: Orthopedic
Date received: 2018-03-09
Decision date: 2019-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Campinas, BR

Download summary PDF View on FDA.gov ↗

Adverse events under product code NKB

product code NKB

Death: 27
Injury: 5,033
Malfunction: 4,140
Total: 9,200

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.