NEOSTEO
FDA Regulatory Profile
NEOSTEO appears in FDA public data with 1 recall, 6 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2236-2021, Class II) was initiated on November 3, 2020. Its most recent 510(k) clearance was granted on February 11, 2022.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 6
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2236-2021 | Class II | Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthoped | November 3, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K212545 | FlexitSystem Knee osteotomy system | February 11, 2022 |
| K192447 | Superelastic Staple | February 28, 2020 |
| K191424 | Interphalangeal Joint Fusion Device Range | August 28, 2019 |
| K153182 | SELF- COMPRESSIVE SCREW | November 25, 2015 |
| K150772 | Snap-Off Self-Compressive Screw | May 8, 2015 |
| K131471 | SELF-COMPRESSIVE SCREW | August 28, 2013 |