ProMIS™ Fixation System
FDA 510(k) clearance K170061 · decided 2017-02-02
Clearance details
- K-number
- K170061
- Device name
- ProMIS™ Fixation System
- Applicant
- Premia Spine, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2017-01-06
- Decision date
- 2017-02-02
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Ramat Poleg, Netanya, IL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| TOPS System (P220002/S010) | Premia Spine, Ltd. | 2025-10-29 |
| TOPS System (P220002/S008) | Premia Spine, Ltd. | 2025-05-29 |
| TOPS System (P220002/S006) | Premia Spine, Ltd. | 2025-03-25 |
| TOPS System (P220002/S007) | Premia Spine, Ltd. | 2025-03-21 |
| TOPS System (P220002/S005) | Premia Spine, Ltd. | 2025-01-17 |
| TOPS System (P220002/S004) | Premia Spine, Ltd. | 2024-06-20 |
| TOPS System (P220002/S003) | Premia Spine, Ltd. | 2023-10-27 |
| TOPS System (P220002/S002) | Premia Spine, Ltd. | 2023-09-07 |