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FDA 510(k)

Excelsior System

K-Number: K253291 · 2026-01-20

ApplicantBlue Ocean Global
Decision Date2026-01-20
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Excelsior System is the device name listed in this FDA 510(k) record. The listed applicant is Blue Ocean Global. It received FDA 510(k) clearance on 2026-01-20 under 510(k) number K253291. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Excelsior System?

Excelsior System is a medical device that received FDA 510(k) clearance on 2026-01-20. The listed applicant is Blue Ocean Global. The 510(k) number is K253291.

When did Excelsior System receive FDA 510(k) clearance?

Excelsior System received FDA 510(k) clearance on 2026-01-20, under 510(k) number K253291.

Who is the listed applicant for Excelsior System?

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

What is the FDA product code for Excelsior System?

The FDA product code for Excelsior System is KTT.

Related Devices (Code: KTT)

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.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbHK252555Medusa Orthopedics Boa External Fixation SystemMedusa Orthopedics, LLC

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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