Pisces-SA 1750-0026
Pisces-SA 1750-0026 is a Class I device made by Osseus Fusion Systems LLC, cleared under FDA 510(k) K213935 on 6 May 2022 and listed in FDA GUDID since 24 May 2022 (UDI-DI B06217500026), 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 | NumberB06217500026 | Date24 May 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK213935 | Date6 May 2022 | StatusActive |
Official records
- FDA 510(k) database K213935
Across registries
- FDA 510(k) K213935 decided 6 May 2022 Active
- FDA GUDID UDI-DI B06217500026 listed 24 May 2022 Listed
Timeline
- Cleared FDA 510(k) K213935
- Listed FDA GUDID B06217500026
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Pisces-SA
- Generic name
- Surgical instrument torque limiter
- Model / Ref / Catalog
- 1750-0026
- Primary DI / UDI-DI
- B06217500026
- 510(k) Number
- FDA product code
- LXH
- GMDN term
- Surgical instrument torque limiter
- Device class
- Class I
- Regulation number
- 888.4540
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Surgical instrument torque limiter.