Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine

K-Number: K223553 · 2023-08-02

ApplicantBrainlab AG
Decision Date2023-08-02
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine is a medical device manufactured by Brainlab AG. It received FDA 510(k) clearance on 2023-08-02 under approval number K223553. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine?

Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine is a medical device that received FDA 510(k) clearance on 2023-08-02. It is manufactured by Brainlab AG. The 510(k) number is K223553.

When was Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine approved by the FDA?

Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine received FDA 510(k) clearance on 2023-08-02, under approval number K223553.

What company makes Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine?

Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine is manufactured by Brainlab AG.

What is the FDA product code for Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine?

The FDA product code for Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine is OLO.

Related Clinical Trials

NCT05565131 Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery COMPLETED NCT07092436 Pediatric Upper-Limb Rehabilitation With PhiCube, a Modular Bilateral End-Effector Device RECRUITING

Related PubMed Literature

PMID: 41987831 From Concept to Clinic: Pre-Clinical Testing and Regulatory Considerations in Spine Implant Development. JOR spine (2026)

Other Devices by Brainlab AG

K153653DICOM Viewer K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM 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

View all 50 devices →

Related Devices (Code: OLO)

K162375Envision 3D: Image Guidance System7D Surgical, Inc. K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. K160385Precision ScrewCryptych Pty, Ltd. K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC K153240Styrker OrthoMap Express Knee SystemStryker Corporate

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.

↑