Flow-Screw™ 102-51-02D
by Flow-Fx, LLC
Flow-Screw™ 102-51-02D is a Class I device made by Flow-Fx, LLC, cleared under FDA 510(k) K142776 on 23 Mar 2015 and listed in FDA GUDID since 8 Feb 2022 (UDI-DI B2671025102D0), 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 | NumberB2671025102D0 | Date8 Feb 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK142776 | Date23 Mar 2015 | StatusActive |
Official records
- FDA 510(k) database K142776
Across registries
- FDA 510(k) K142776 decided 23 Mar 2015 Active
- FDA GUDID UDI-DI B2671025102D0 listed 8 Feb 2022 Listed
Timeline
- Cleared FDA 510(k) K142776
- Listed FDA GUDID B2671025102D0
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Flow-Screw™
- Generic name
- Orthopaedic coaxial injection applicator
- Model / Ref / Catalog
- 102-51-02D
- Primary DI / UDI-DI
- B2671025102D0
- 510(k) Number
- FDA product code
- LXH
- GMDN term
- Orthopaedic coaxial injection applicator
- Device class
- Class I
- Regulation number
- 888.4540
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization