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Teligen 286006064S

by Medos International Sàrl

Teligen 286006064S is a Class II device made by Medos International Sàrl, cleared under FDA 510(k) K213978 on 18 Oct 2022 and listed in FDA GUDID since 10 Feb 2024 (UDI-DI 10705034604541), 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) K213978

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 Number10705034604541 UDI-DI Date10 Feb 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK213978 Date18 Oct 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K213978 decided 18 Oct 2022 Active
  • FDA GUDID UDI-DI 10705034604541 listed 10 Feb 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K213978
  2. Listed FDA GUDID 10705034604541

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Teligen
Generic name
Orthopaedic surgical procedure kit, non-medicated, single-use
Model / Ref / Catalog
286006064S
Primary DI / UDI-DI
10705034604541
510(k) Number
FDA product code
HRX, LXH
GMDN term
Orthopaedic surgical procedure kit, non-medicated, single-use
Device class
Class II
Regulation number
888.1100, 888.4540
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orthopaedic surgical procedure kit, non-medicated, single-use

Cleared under the same submission (K213978)

and 1 more cleared under K213978

Similar devices

Other devices filed under FDA product code HRX (Arthroscope).

Other devices from Medos International SARL

See all devices from Medos International SARL →

Properties

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