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FDA 510(k)

Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM

K-Number: K170816 · 2017-09-26

ApplicantBrainlab AG
Decision Date2017-09-26
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM is a medical device manufactured by Brainlab AG. It received FDA 510(k) clearance on 2017-09-26 under approval number K170816. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM?

Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM is a medical device that received FDA 510(k) clearance on 2017-09-26. It is manufactured by Brainlab AG. The 510(k) number is K170816.

When was Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM approved by the FDA?

Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM received FDA 510(k) clearance on 2017-09-26, under approval number K170816.

What company makes Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM?

Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM is manufactured by Brainlab AG.

What is the FDA product code for Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM?

The FDA product code for Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM is LLZ.

Related Clinical Trials

NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT07422623 Hallux Valgus Correction Surgery Recovery Using Semiconductor Embedded Therapeutic Sleeves ENROLLING_BY_INVITATION NCT07589023 A Retrospective Review: Outcomes of the REFLECT™ System for Idiopathic Scoliosis NOT_YET_RECRUITING NCT06868979 Optical Imaging in X-linked Disorders. RECRUITING NCT03031587 Validation of Thermometric Cardiac Imaging by MRI COMPLETED NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

Related PubMed Literature

PMID: 41987831 From Concept to Clinic: Pre-Clinical Testing and Regulatory Considerations in Spine Implant Development. JOR spine (2026) PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026)

Other Devices by Brainlab AG

K153653DICOM Viewer K170750RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review K172820Microscope Navigation Software K190250Microscope Navigation K183605Spine & Trauma Navigation K191285Spine & Trauma Navigation

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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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