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)

LAGUNA SIZE 8 PEDICLE SCREW SYSTEM

K-Number: K091995 · 2009-08-07

ApplicantAllez Spine, LLC
Decision Date2009-08-07
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LAGUNA SIZE 8 PEDICLE SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Allez Spine, LLC. It received FDA 510(k) clearance on 2009-08-07 under 510(k) number K091995. 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 LAGUNA SIZE 8 PEDICLE SCREW SYSTEM?

LAGUNA SIZE 8 PEDICLE SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2009-08-07. The listed applicant is Allez Spine, LLC. The 510(k) number is K091995.

When did LAGUNA SIZE 8 PEDICLE SCREW SYSTEM receive FDA 510(k) clearance?

LAGUNA SIZE 8 PEDICLE SCREW SYSTEM received FDA 510(k) clearance on 2009-08-07, under 510(k) number K091995.

Who is the listed applicant for LAGUNA SIZE 8 PEDICLE SCREW SYSTEM?

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

What is the FDA product code for LAGUNA SIZE 8 PEDICLE SCREW SYSTEM?

The FDA product code for LAGUNA SIZE 8 PEDICLE SCREW 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 Allez 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.

K091219DEL MAR MONOAXIAL PEDICLE SCREW SYSTEMK083826LAGUNA POLYAXIAL PEDICLE SCREW SYSTEMK072678LAGUNA SIZE 8 PEDICLE SCREWK070460ALLEZ SPINE CROSS CONNECTORSK051275LAGUNA MONOAXIAL PEDICLE SCREW SYSTEMK050060LAGUNA PEDICLE SCREW SYSTEM

View all 7 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.

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

View on FDA Database →

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

↑