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)

Spinal Inner Fixation System

K-Number: K222031 · 2022-10-28

ApplicantChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.
Decision Date2022-10-28
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Spinal Inner Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.. It received FDA 510(k) clearance on 2022-10-28 under 510(k) number K222031. 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 Spinal Inner Fixation System?

Spinal Inner Fixation System is a medical device that received FDA 510(k) clearance on 2022-10-28. The listed applicant is Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.. The 510(k) number is K222031.

When did Spinal Inner Fixation System receive FDA 510(k) clearance?

Spinal Inner Fixation System received FDA 510(k) clearance on 2022-10-28, under 510(k) number K222031.

Who is the listed applicant for Spinal Inner Fixation System?

The FDA 510(k) record lists Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Spinal Inner Fixation System?

The FDA product code for Spinal Inner Fixation System is NKB.

Other records listing Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. 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.

K232394Internal Locking Plate and Screw Fixation SystemK230456SGM Femoral Nail SystemK223776PEEK Spinal Infusion Cage

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.

↑