TOPS System
FDA premarket approval P220002/S004 · decided 2024-06-20
Approval details
- PMA number
- P220002
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TOPS System
- Generic name
- Prosthesis, posterior spinal elements
- Applicant
- Premia Spine, Ltd.
- Date received
- 2023-09-28
- Decision date
- 2024-06-20
- Days to decision
- 266 days
- Decision code
- APPR
- Product code
- QWK
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Netanya
- Statement
- Approval for the use of additional pedicle screw components (slender tulip cannulated-tapered and non-cannulated screws) with the TOPS System.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ProMIS Extension Rod System (K232719) | Premia Spine, Ltd. | 2023-11-21 |
| ProMIS™ Fixation System (K231844) | Premia Spine, Ltd. | 2023-07-07 |
| Premia Spine XL Instruments (K191854) | Premia Spine, Ltd. | 2019-10-08 |
| VersaLink™ Fixation System (K182598) | Premia Spine, Ltd. | 2018-11-13 |
| ProMIS™ Fixation System (K170061) | Premia Spine, Ltd. | 2017-02-02 |
| ProMIS Fixation System (K150380) | Premia Spine, Ltd. | 2015-07-17 |