PREMIA SPINE LTD
FDA Regulatory Profile
PREMIA SPINE LTD appears in FDA public data with 1 recall, 6 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2516-2025, Class II) was initiated on July 16, 2025. Its most recent 510(k) clearance was granted on November 21, 2023.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 6
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2516-2025 | Class II | TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Mode | July 16, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K232719 | ProMIS Extension Rod System | November 21, 2023 |
| K231844 | ProMIS Fixation System | July 7, 2023 |
| K191854 | Premia Spine XL Instruments | October 8, 2019 |
| K182598 | VersaLink Fixation System | November 13, 2018 |
| K170061 | ProMIS Fixation System | February 2, 2017 |
| K150380 | ProMIS Fixation System | July 17, 2015 |