Foundation Surgical Navigated Lateral Disc Prep Instruments— 510(k) K260011
Substantially EquivalentFoundation Surgical Group, Inc.
FDA 510(k) clearance K260011 for Foundation Surgical Navigated Lateral Disc Prep Instruments, Substantially Equivalent on 2026-04-16. Applicant: Foundation Surgical Group, Inc.. Device class: 2.
Summary
Foundation Surgical Group's Foundation Surgical Navigated Lateral Disc Prep Instruments are filed under product code OLO (Orthopedic Stereotaxic Instrument).
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.
Foundation Surgical Group filed from Scottsdale, Arizona. The record shows 104 calendar days from receipt to decision (January 2 to April 16, 2026).
Clearance details
- Applicant
- Foundation Surgical Group, Inc.
- Product code
- Product 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
- Scottsdale, AZ, US
Recent devices under product code OLO
view allMore clearances from Foundation Surgical Group, Inc.
view allAdverse 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.