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Reduction Rod 111221000

by Double Medical Technology Inc.

Reduction Rod 111221000 is a Class II device made by Double Medical Technology Inc., cleared under FDA 510(k) K131609 on 21 May 2014 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 06902139112118), 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) K131609

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 Number06902139112118 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK131609 Date21 May 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K131609 decided 21 May 2014 Active
  • FDA GUDID UDI-DI 06902139112118 listed 1 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K131609
  2. Listed FDA GUDID 06902139112118

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Reduction Rod
Generic name
Orthopaedic bone-reduction tool
Model / Ref / Catalog
111221000
Primary DI / UDI-DI
06902139112118
510(k) Number
FDA product code
HSB
GMDN term
Orthopaedic bone-reduction tool
Device class
Class II
Regulation number
888.3020
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices in this category

Other devices filed under Orthopaedic bone-reduction tool.

Other devices from Double Medical Technology Inc.

See all devices from Double Medical Technology Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)