Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)— 510(k) K252597

Name: FDA 510(k) clearance K252597
Creator: U.S. Food and Drug Administration
Published: 2026-02-19

Substantially Equivalent

Alphatec Spine, Inc.

FDA 510(k) clearance K252597 for Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation), Substantially Equivalent on 2026-02-19. Applicant: Alphatec Spine, Inc.. Device class: 2.

Summary

Alphatec Spine lists the Valence Robotic Navigation System and Valence Robotic Navigation Instruments, the latter marked "For Use with StealthStation." Both are filed under product code OLO, orthopedic stereotaxic instrument. The record doesn't describe either one further.

Class II, 21 CFR 882.4560. The Orthopedic review panel handled it as a Traditional 510(k), though the record lists Neurology as the classification panel.

Alphatec Spine filed from Carlsbad, California. FDA found it substantially equivalent 188 calendar days after receipt (August 15, 2025 to February 19, 2026).

Clearance details

Applicant: Alphatec Spine, Inc.
Product code: Product code OLO
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2025-08-15
Decision date: 2026-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OLO

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K262567 — GPS Ankle2026-10-26
K260403 — 7D Surgical System (10-0001)2026-10-19
K263234 — TMINI Miniature Robotic System2026-10-16
K263154 — CarboClear® Cervical Navigated Instruments2026-10-09
K262257 — Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine2026-09-30

More clearances from Alphatec Spine, Inc.

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K262646 — Calibrate MAX System +3 more2026-10-21
K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System2026-07-14
K253216 — IntraOp Alignment System; CONTOUR3D Bending System2026-06-25
K253615 — Invictus Bands System2026-03-25
K252842 — SafeOp 3: Neural Informatix System2026-01-11

Adverse events under product code OLO

product code OLO

Death: 11
Injury: 2,799
Malfunction: 11,105
Other: 1
Total: 13,916

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.