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)

Inertia Pedicle Screw and Deformity Correxxion System

K-Number: K153453 · 2016-04-26

ApplicantNexxt Spine, LLC
Decision Date2016-04-26
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Inertia Pedicle Screw and Deformity Correxxion System is the device name listed in this FDA 510(k) record. The listed applicant is Nexxt Spine, LLC. It received FDA 510(k) clearance on 2016-04-26 under 510(k) number K153453. 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 Inertia Pedicle Screw and Deformity Correxxion System?

Inertia Pedicle Screw and Deformity Correxxion System is a medical device that received FDA 510(k) clearance on 2016-04-26. The listed applicant is Nexxt Spine, LLC. The 510(k) number is K153453.

When did Inertia Pedicle Screw and Deformity Correxxion System receive FDA 510(k) clearance?

Inertia Pedicle Screw and Deformity Correxxion System received FDA 510(k) clearance on 2016-04-26, under 510(k) number K153453.

Who is the listed applicant for Inertia Pedicle Screw and Deformity Correxxion System?

The FDA 510(k) record lists Nexxt Spine, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Inertia Pedicle Screw and Deformity Correxxion System?

The FDA product code for Inertia Pedicle Screw and Deformity Correxxion System is NKB.

Related Clinical Trials

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.

NCT05565131Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine SurgeryCOMPLETED

Other records listing Nexxt Spine, LLC 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.

K243838NEXXT MATRIXX® SI SystemK240690STRUXXURE® MCS Anterior Cervical Plate SystemK231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemK221905INERTIA CONNEXX Modular Pedicle Screw SystemK220291NEXXT SPINE NAVIGATION SystemK202230NEXXT MATRIXX Stand Alone ALIF System

View all 17 devices →

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.

↑