Flow-Screw™ 55-2042

by Flow-Fx, LLC 2 variants

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberB2675520420 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

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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Withdrawn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: 55-2042

Primary DI / UDI-DI: B2675520420
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)

Supplied sterile: No
Implantable: No
Contains latex: No
Over-the-counter: No
Convenience kit: No
Combination product: No
HCT/P: No
Premarket exempt: No
Serial number: No
Expiration date: No
Manufacturing date: No