Spinr Spn-1005
by ZIEN Medical Technologies, LLC
Spinr Spn-1005 is a Class II device made by ZIEN Medical Technologies, LLC, cleared under FDA 510(k) K141054 on 10 Dec 2014 and listed in FDA GUDID since 3 May 2023 (UDI-DI B090SPN10050), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB090SPN10050 | Date3 May 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK141054 | Date10 Dec 2014 | StatusActive |
Official records
- FDA 510(k) database K141054
Across registries
- FDA 510(k) K141054 decided 10 Dec 2014 Active
- FDA GUDID UDI-DI B090SPN10050 listed 3 May 2023 Listed
Timeline
- Cleared FDA 510(k) K141054
- Listed FDA GUDID B090SPN10050
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Spinr
- Generic name
- Torque manipulation device
- Model / Ref / Catalog
- SPN-1005
- Primary DI / UDI-DI
- B090SPN10050
- 510(k) Number
- FDA product code
- DQX
- GMDN term
- Torque manipulation device
- Device class
- Class II
- Regulation number
- 870.1330
- GUDID distribution status
- In Commercial Distribution
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