TOPS System
FDA premarket approval P220002/S010 · decided 2025-10-29
Approval details
- PMA number
- P220002
- Supplement
- S010
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TOPS System
- Generic name
- Prosthesis, posterior spinal elements
- Applicant
- Premia Spine, Ltd.
- Date received
- 2025-09-30
- Decision date
- 2025-10-29
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- QWK
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Netanya
- Statement
- introduction of a new plug sorting jig, adjustment to the plug cutting and insertion machine, and minor dimensional changes to the plug and top plate components to and improve sealing performance at the Premia Spine Ltd, Ramat Poleg, Netanya, Isreal and TAV Medical Ltd, Israel facilities
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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 |