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FDA 510(k)

UCR SPINAL SYSTEM

K-Number: K043232 · 2004-12-21

ApplicantSeaspine
Decision Date2004-12-21
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UCR SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Seaspine. It received FDA 510(k) clearance on 2004-12-21 under 510(k) number K043232. 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 UCR SPINAL SYSTEM?

UCR SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2004-12-21. The listed applicant is Seaspine. The 510(k) number is K043232.

When did UCR SPINAL SYSTEM receive FDA 510(k) clearance?

UCR SPINAL SYSTEM received FDA 510(k) clearance on 2004-12-21, under 510(k) number K043232.

Who is the listed applicant for UCR SPINAL SYSTEM?

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

What is the FDA product code for UCR SPINAL SYSTEM?

The FDA product code for UCR SPINAL 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Seaspine 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.

K040130ANTERIOR LUMBAR BUTTRESS SYSTEMK032739UCR SPINAL SYSTEMK032368SONOMA ANTERIOR CERVICAL PLATE SYSTEMK031381UCR SPINAL SYSTEM, LAMINAR HOOKS, PEDICLE HOOKS, AND INSTRUMENTS

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.

K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim SirketiK262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyXenix MedicalK262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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