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)

GMA 2.0 Pedicle Screw System

K-Number: K192915 · 2019-11-13

ApplicantGrafton Medical Alliance
Decision Date2019-11-13
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GMA 2.0 Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Grafton Medical Alliance. It received FDA 510(k) clearance on 2019-11-13 under 510(k) number K192915. 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 GMA 2.0 Pedicle Screw System?

GMA 2.0 Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2019-11-13. The listed applicant is Grafton Medical Alliance. The 510(k) number is K192915.

When did GMA 2.0 Pedicle Screw System receive FDA 510(k) clearance?

GMA 2.0 Pedicle Screw System received FDA 510(k) clearance on 2019-11-13, under 510(k) number K192915.

Who is the listed applicant for GMA 2.0 Pedicle Screw System?

The FDA 510(k) record lists Grafton Medical Alliance as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GMA 2.0 Pedicle Screw System?

The FDA product code for GMA 2.0 Pedicle Screw System is NKB.

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.

↑