McGinley Orthopaedic Innovations
FDA Regulatory Profile
McGinley Orthopaedic Innovations has 0 FDA recalls, 1 inspection, 1 510(k) clearance and 0 compliance actions on record.
- Latest inspection
- Jun 5, 2025 · VAI
- Latest 510(k)
- Oct 19, 2026
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 1 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 1 | Nov 11, 2026 | Newest record Nov 5, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent FDA Inspections
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3011569539 | Casper, WY | 1 | Jun 5, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K261189 | Freedom Nail Ankle Fusion System | Oct 19, 2026 |