TOPS System
FDA premarket approval P220002/S002 · decided 2023-09-07
Approval details
- PMA number
- P220002
- Supplement
- S002
- 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
- 2023-08-10
- Decision date
- 2023-09-07
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- QWK
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Netanya
- Statement
- Information provided by the firm to support the following changes: 1. The addition of two (2) semi-automated assembly machines (Boot to TOP Plate machine-EGEQ88244 and Core Assembly to TOP Plate-EGEQ88242), as alternative to the current manual process, for certain assembly steps of the TOPS; and 2) Flip the insertion orientation of the Polycarbonate Urethane (PcU) Plug prior to its insertion into the TOPS Top Plate.
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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 |