Flow-Screw™ 55-0052

by Flow-Fx, LLC 2 variants

Flow-Screw™ 55-0052 is a Class II device made by Flow-Fx, LLC, cleared under FDA 510(k) K142776 on 23 Mar 2015 and listed in FDA GUDID since 22 Jun 2018 (UDI-DI B2675500520), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberB2675500520 UDI-DI	Date22 Jun 2018Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK142776	Date23 Mar 2015Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K142776

Across registries

2 registries list this device

FDA 510(k) K142776 decided 23 Mar 2015 Active
FDA GUDID UDI-DI B2675500520 listed 22 Jun 2018 Listed

Timeline

2 dated events

23 Mar 2015 Cleared FDA 510(k) K142776
22 Jun 2018 Listed FDA GUDID B2675500520

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Flow-Screw™
Generic name: Orthopaedic bone screw, non-bioabsorbable, non-sterile
Model / Ref / Catalog: 55-0052

Primary DI / UDI-DI: B2675500520
510(k) Number: K142776
FDA product code: HWC
GMDN term: Orthopaedic bone screw, non-bioabsorbable, non-sterile

Device class: Class II
Regulation number: 888.3040
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

Other devices from Flow-Fx, LLC

See all devices from Flow-Fx, LLC →

Properties

Sterilise before use
Single use
Prescription use
Lot / batch number

Other properties (11, all answered No)