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2.0S-Mini Screw 030160019

by Double Medical Technology Inc.

2.0S-Mini Screw 030160019 is a Class II device made by Double Medical Technology Inc., cleared under FDA 510(k) K130108 on 19 Apr 2013 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 06942782410278), 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) K130108

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 Number06942782410278 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK130108 Date19 Apr 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K130108 decided 19 Apr 2013 Active
  • FDA GUDID UDI-DI 06942782410278 listed 1 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K130108
  2. Listed FDA GUDID 06942782410278

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
2.0S-Mini Screw
Generic name
Orthopaedic bone screw (non-sliding)
Model / Ref / Catalog
030160019
Primary DI / UDI-DI
06942782410278
510(k) Number
FDA product code
HWC, HRS
GMDN term
Orthopaedic bone screw (non-sliding)
Device class
Class II
Regulation number
888.3040, 888.3030
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Length — 19.0 Millimeter

Related devices

Category: Orthopaedic bone screw (non-sliding)

Cleared under the same submission (K130108)

and 8 more cleared under K130108

Other devices from Double Medical Technology Inc.

See all devices from Double Medical Technology Inc. →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)