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Milagro 231811

by Medos International Sàrl

Milagro 231811 is a Class II device made by Medos International Sàrl, cleared under FDA 510(k) K143660 on 21 May 2015 (1 earlier submission) and listed in FDA GUDID since 1 Sep 2015 (UDI-DI 10886705020416), 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 StatesGUDID listing Number10886705020416 UDI-DI Date1 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK143660 Date21 May 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K143660 decided 21 May 2015 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10886705020416 listed 1 Sep 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K120589
  2. Cleared FDA 510(k) K143660
  3. Listed FDA GUDID 10886705020416

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Milagro
Generic name
Bioabsorbable orthopaedic bone screw
Model / Ref / Catalog
231811
Primary DI / UDI-DI
10886705020416
510(k) Number
FDA product code
MAI
GMDN term
Bioabsorbable orthopaedic bone screw
Device class
Class II
Regulation number
888.3030
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

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Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)