Flow-Screw™ 102-21
by Flow-Fx, LLC
Flow-Screw™ 102-21 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 18 Dec 2020 (UDI-DI B267102210), 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 | NumberB267102210 | Date18 Dec 2020 | 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 B267102210 listed 18 Dec 2020 Listed
Timeline
- Cleared FDA 510(k) K142776
- Listed FDA GUDID B267102210
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Flow-Screw™
- Generic name
- Surgical drill guide, reusable
- Model / Ref / Catalog
- 102-21
- Primary DI / UDI-DI
- B267102210
- 510(k) Number
- FDA product code
- FZX
- GMDN term
- Surgical drill guide, reusable
- Device class
- Class I
- Regulation number
- 878.4800
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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