Flow-Screw™ 102-01-00
by Flow-Fx, LLC
Flow-Screw™ 102-01-00 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 B26710201000), 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 | NumberB26710201000 | 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 B26710201000 listed 18 Dec 2020 Listed
Timeline
- Cleared FDA 510(k) K142776
- Listed FDA GUDID B26710201000
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Flow-Screw™
- Generic name
- Cannulated surgical drill bit, single-use, non-sterile
- Model / Ref / Catalog
- 102-01-00
- Primary DI / UDI-DI
- B26710201000
- 510(k) Number
- FDA product code
- HTW
- GMDN term
- Cannulated surgical drill bit, single-use, non-sterile
- Device class
- Class I
- Regulation number
- 888.4540
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices
Other devices filed under FDA product code HTW (Bit, Drill).
- Cannulated Hex Bit 909730 by Biomet Orthopedics, Inc.
- A.L.P.S.® Proximal Humerus Plating System 110017737 by Biomet Orthopedics, Inc.
- SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM PEG-PGD128 by Orthopediatrics Canada ULC
- ACUMED 80-2378 by ACUMED LLC
- MicroFX OCD 234-200-200 by Stryker Corp.
- VALOR 415S002350 by WRIGHT MEDICAL TECHNOLOGY, INC.
- APEX Knee System KR-55110 by OMNIlife science, Inc.
- 2318-48-06 00-2318-048-06 by Zimmer, Inc.
- DRILL BIT by Plastafil, Inc.
- 4806-85-15 00-4806-085-15 by Zimmer, Inc.