K252597 is an FDA 510(k) clearance for the Valence Robotic Navigation System. This device is classified as a Orthopedic Stereotaxic Instrument (Class II - Special Controls, product code OLO).
Submitted by Alphatec Spine, Inc. (Carlsbad, US). The FDA issued a Cleared decision on February 19, 2026, 188 days after receiving the submission on August 15, 2025.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 882.4560. Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw..
| 510(k) Number | K252597 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 15, 2025 |
| Decision Date | February 19, 2026 |
| Days to Decision | 188 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OLO — Orthopedic Stereotaxic Instrument |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4560 |
| Definition | Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw. |