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TACTIX Vector TVX-TSNR-K

by Vilex, Inc.

TACTIX Vector TVX-TSNR-K is a suture/ligature tightener (FDA Class I; FDA product code LXH, Orthopedic Manual Surgical Instrument) made by Vilex, Inc., cleared under FDA 510(k) K240035 on 1 Aug 2024 and listed in FDA GUDID since 6 Aug 2025 (UDI-DI 00841731133861), active as of 22 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 22 Oct 2026

Documents

510(k) K240035

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841731133861 UDI-DI Date6 Aug 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK240035 Date1 Aug 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K240035 decided 1 Aug 2024 Active
  • FDA GUDID UDI-DI 00841731133861 listed 6 Aug 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K240035
  2. Listed FDA GUDID 00841731133861

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
TACTIX Vector
Generic name
Suture/ligature tightener, single-use
Model / Ref / Catalog
TVX-TSNR-K
Primary DI / UDI-DI
00841731133861
510(k) Number
FDA product code
LXH
GMDN term
Suture/ligature tightener, single-use
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution

Related devices

Category: Suture/ligature tightener, single-use

Similar devices

Other devices filed under FDA product code LXH (Orthopedic Manual Surgical Instrument).

Other devices from Vilex, Inc.

See all devices from Vilex, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)