FDA 510(k)

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

K-Nummer: K252597 · 2026-02-19

Entscheidungsdatum2026-02-19

ProduktcodeOLO

BeratungsausschussNE

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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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Offizielle Quelle

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