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TELIGEN System

by Medos International SARL

510(k) K213978

TELIGEN System is a Class II device made by Medos International SARL, cleared under FDA 510(k) K213978 on 18 Oct 2022, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK213978 Date18 Oct 2022ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
HRX
Device class
Class II
Regulation
21 CFR Part 888.1100
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K213978

6 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K213978
UDI-DISize and differences
TELIGEN 186000000S
Medos International Sàrl
186000000S / 186000000S10705034560359
Single use: yes
On the market
TELIGEN 186000002S
Medos International Sàrl
186000002S / 186000002S10705034571607
Single use: yes
On the market
TELIGEN 286003210
Medos International Sàrl
286003210 / 28600321010705034560526
Single use: no
On the market
TELIGEN 286006061S
Depuy Spine, Inc.
286006061S / 286006061S10705034604510
Single use: yes
On the market
TELIGEN 286006063S
Medos International Sàrl
286006063S / 286006063S10705034604534
Single use: yes
On the market
TELIGEN 286006064S
Medos International Sàrl
286006064S / 286006064S10705034604541
Single use: yes
On the market

Similar devices

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

Other devices from Medos International SARL

See all devices from Medos International SARL →