Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)— 510(k) K252597
Substantially EquivalentAlphatec 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.
Clearance details
- Applicant
- Alphatec Spine, Inc.
- Product code
- Code OLO
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
Recent devices under product code OLO
view allMore clearances from Alphatec Spine, Inc.
view all- K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System
- K253216 — IntraOp Alignment System; CONTOUR3D Bending System
- K253615 — Invictus Bands System
- K252842 — SafeOp 3: Neural Informatix System
- K251965 — Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)
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, through . 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.