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Spinr 5X-Gw

by ZIEN Medical Technologies, LLC

Spinr 5X-Gw is a Class II device made by ZIEN Medical Technologies, LLC, cleared under FDA 510(k) K141054 on 10 Dec 2014 and listed in FDA GUDID since 21 Jul 2022 (UDI-DI B0905XGW0), 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) K141054

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 NumberB0905XGW0 UDI-DI Date21 Jul 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK141054 Date10 Dec 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K141054 decided 10 Dec 2014 Active
  • FDA GUDID UDI-DI B0905XGW0 listed 21 Jul 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K141054
  2. Listed FDA GUDID B0905XGW0

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Spinr
Generic name
Torque manipulation device
Model / Ref / Catalog
5X-GW
Primary DI / UDI-DI
B0905XGW0
510(k) Number
FDA product code
DQX
GMDN term
Torque manipulation device
Device class
Class II
Regulation number
870.1330
GUDID distribution status
In Commercial Distribution

Related devices

Category: Torque manipulation device

Cleared under the same submission (K141054)

Similar devices

Other devices filed under FDA product code DQX (Wire, Guide, Catheter).

Other devices from ZIEN Medical Technologies, LLC

See all devices from ZIEN Medical Technologies, LLC →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)