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FDA 510(k)

Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine

K-Number: K262257 · 2026-09-30

ApplicantBrainlab SE
Decision Date2026-09-30
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab SE. It received FDA 510(k) clearance on 2026-09-30 under 510(k) number K262257. 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 (3.0); Spine & Trauma Navigation; Alignment System Spine?

Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine is a medical device that received FDA 510(k) clearance on 2026-09-30. The listed applicant is Brainlab SE. The 510(k) number is K262257.

When did Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine receive FDA 510(k) clearance?

Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine received FDA 510(k) clearance on 2026-09-30, under 510(k) number K262257.

Who is the listed applicant for Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine?

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

What is the FDA product code for Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine?

The FDA product code for Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine is OLO.

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.

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Other records listing Brainlab SE 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.

K254010ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface

Related Devices (Code: OLO)

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.

K262506Remex Spine Surgery Navigation - Universal InstrumentsRemex Medical Corp.K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation CentreK261205SPINEART Navigation Instrument SystemSpineart SAK262121Ion-L Navigated InstrumentsSurGenTec, LLCK261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics

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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