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FDA 510(k)

Statera-C™ Spinal System

K-Number: K233332 · 2023-11-27

ApplicantK&J Consulting Corp.
Decision Date2023-11-27
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Statera-C™ Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is K&J Consulting Corp.. It received FDA 510(k) clearance on 2023-11-27 under 510(k) number K233332. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Statera-C™ Spinal System?

Statera-C™ Spinal System is a medical device that received FDA 510(k) clearance on 2023-11-27. The listed applicant is K&J Consulting Corp.. The 510(k) number is K233332.

When did Statera-C™ Spinal System receive FDA 510(k) clearance?

Statera-C™ Spinal System received FDA 510(k) clearance on 2023-11-27, under 510(k) number K233332.

Who is the listed applicant for Statera-C™ Spinal System?

The FDA 510(k) record lists K&J Consulting Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Statera-C™ Spinal System?

The FDA product code for Statera-C™ Spinal System is NKG.

Other records listing K&J Consulting Corp. 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.

K250335IVA & AEON Cervical and Lumbar Cage SystemK232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone SystemK232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK231460FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System, and Osprey™ Anterior Cervical Plate SystemK212038K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage

Related Devices (Code: NKG)

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.

K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw SystemCarboFix Orthopedics , Ltd.K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AGK253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.K251725ANAX™ OCT Spinal SystemCg Medtech 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.

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