Skip to content

Flow-Screw™ 102-16-00

by Flow-Fx, LLC 2 variants

Flow-Screw™ 102-16-00 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 22 Jul 2024 (UDI-DI B26710216000), 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

510(k) K142776

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB26710216000 UDI-DI Date22 Jul 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK142776 Date23 Mar 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K142776 decided 23 Mar 2015 Active
  • FDA GUDID UDI-DI B26710216000 listed 22 Jul 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K142776
  2. Listed FDA GUDID B26710216000

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Flow-Screw™
Generic name
Orthopaedic implant driver
Model / Ref / Catalog
102-16-00
Primary DI / UDI-DI
B26710216000
510(k) Number
FDA product code
HXX
GMDN term
Orthopaedic implant driver
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic implant driver

Cleared under the same submission (K142776)

and 8 more cleared under K142776

Similar devices in this category

Other devices filed under Orthopaedic implant driver.

Other devices from Flow-Fx, LLC

See all devices from Flow-Fx, LLC →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)