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)

FUSELOX LUMBAR INTERBODY FUSION DEVICE

K-Number: K122956 · 2012-10-25

ApplicantCaptiva Spine
Decision Date2012-10-25
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FUSELOX LUMBAR INTERBODY FUSION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Captiva Spine. It received FDA 510(k) clearance on 2012-10-25 under 510(k) number K122956. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUSELOX LUMBAR INTERBODY FUSION DEVICE?

FUSELOX LUMBAR INTERBODY FUSION DEVICE is a medical device that received FDA 510(k) clearance on 2012-10-25. The listed applicant is Captiva Spine. The 510(k) number is K122956.

When did FUSELOX LUMBAR INTERBODY FUSION DEVICE receive FDA 510(k) clearance?

FUSELOX LUMBAR INTERBODY FUSION DEVICE received FDA 510(k) clearance on 2012-10-25, under 510(k) number K122956.

Who is the listed applicant for FUSELOX LUMBAR INTERBODY FUSION DEVICE?

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

What is the FDA product code for FUSELOX LUMBAR INTERBODY FUSION DEVICE?

The FDA product code for FUSELOX LUMBAR INTERBODY FUSION DEVICE is MAX.

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 Captiva Spine 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.

K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemK131538CAPLOX II PEDICLE SCREW SYSTEM/TOWERLOX PEDICLE SCREW SYSTEMK122332TOWERLOX PEDICLE SCREW SYSTEM

Related Devices (Code: MAX)

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.

K261049SCALA® TLSpineart SAK261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development 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.

↑