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Cougar 189135112

by Medos International Sàrl

Cougar 189135112 is a Class II device made by Medos International Sàrl, cleared under FDA 510(k) K173787 on 11 Jun 2018 (1 earlier submission) and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 10705034161914), 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

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK173787 Date11 Jun 2018DecidedStatusActive
United StatesGUDID listing Number10705034161914 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K173787 decided 11 Jun 2018 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10705034161914 listed 24 Sep 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K082128
  2. Listed FDA GUDID 10705034161914
  3. Cleared FDA 510(k) K173787

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Cougar
Generic name
Polymeric spinal interbody fusion cage
Model / Ref / Catalog
189135112
Primary DI / UDI-DI
10705034161914
510(k) Number
FDA product code
MAX
GMDN term
Polymeric spinal interbody fusion cage
Device class
Class II
Regulation number
888.3080
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Polymeric spinal interbody fusion cage

Cleared under the same submission (K082128)

and 8 more cleared under K082128

Cleared under the same submission (K173787)

and 8 more cleared under K173787

Similar devices

Other devices filed under FDA product code MAX (Intervertebral fusion device with bone graft, lumbar).

Other devices from Medos International SARL

See all devices from Medos International SARL →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (10, all answered No)