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FDA 510(k)

HOLO Portal™ Surgical Guidance System

K-Number: K231611 · 2023-08-31

ApplicantSurgalign Spine Technologies
Decision Date2023-08-31
Product CodeSBF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HOLO Portal™ Surgical Guidance System is a medical device manufactured by Surgalign Spine Technologies. It received FDA 510(k) clearance on 2023-08-31 under approval number K231611. The device is classified under product code SBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOLO Portal™ Surgical Guidance System?

HOLO Portal™ Surgical Guidance System is a medical device that received FDA 510(k) clearance on 2023-08-31. It is manufactured by Surgalign Spine Technologies. The 510(k) number is K231611.

When was HOLO Portal™ Surgical Guidance System approved by the FDA?

HOLO Portal™ Surgical Guidance System received FDA 510(k) clearance on 2023-08-31, under approval number K231611.

What company makes HOLO Portal™ Surgical Guidance System?

HOLO Portal™ Surgical Guidance System is manufactured by Surgalign Spine Technologies.

What is the FDA product code for HOLO Portal™ Surgical Guidance System?

The FDA product code for HOLO Portal™ Surgical Guidance System is SBF.

Related Clinical Trials

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025)

Other Devices by Surgalign Spine Technologies

K221403Cortera Spinal Fixation System K211254ARAI Surgical Navigation System

Related Devices (Code: SBF)

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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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