Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Gm Dos Reis Industria E Comerico Ltda.. It received FDA 510(k) clearance on 2019-02-01 under 510(k) 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. The listed applicant is Gm Dos Reis Industria E Comerico Ltda.. The 510(k) number is K180626.

When did Pedimax II - Pedicular Screw Spinal System receive FDA 510(k) clearance?

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

Who is the listed applicant for Pedimax II - Pedicular Screw Spinal System?

The FDA 510(k) record lists Gm Dos Reis Industria E Comerico Ltda. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Gm Dos Reis Industria E Comerico Ltda. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K223114Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsK182718Mini and Micro Fragments Reconstruction System – GMReis

Related Devices (Code: NKB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.K253943Tiger 2 SystemZavation Medical Products, LLCK261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.

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.

↑