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FDA 510(k)

Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)

K-Number: K252597 · 2026-02-19

ApplicantAlphatec Spine, Inc.
Decision Date2026-02-19
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2026-02-19 under 510(k) number K252597. 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 Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)?

Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) is a medical device that received FDA 510(k) clearance on 2026-02-19. The listed applicant is Alphatec Spine, Inc.. The 510(k) number is K252597.

When did Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) receive FDA 510(k) clearance?

Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) received FDA 510(k) clearance on 2026-02-19, under 510(k) number K252597.

Who is the listed applicant for Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)?

The FDA 510(k) record lists Alphatec Spine, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)?

The FDA product code for Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) is OLO.

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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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