Draco Htr-03-010728

by Hnm Total Recon LLC

Draco Htr-03-010728 is a Class II device made by Hnm Total Recon LLC, cleared under FDA 510(k) K050457 on 14 Mar 2005 and listed in FDA GUDID since 11 Dec 2017 (UDI-DI 00841742121789), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00841742121789 UDI-DI	Date11 Dec 2017Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK050457	Date14 Mar 2005Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00841742121789
FDA 510(k) database 510(k) number K050457

Across registries

2 registries list this device

FDA 510(k) K050457 decided 14 Mar 2005 Active
FDA GUDID UDI-DI 00841742121789 listed 11 Dec 2017 Listed

Timeline

2 dated events

14 Mar 2005 Cleared FDA 510(k) K050457
11 Dec 2017 Listed FDA GUDID 00841742121789

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Draco
Generic name: External orthopaedic fixation system, single-use
Model / Ref / Catalog: HTR-03-010728

Primary DI / UDI-DI: 00841742121789
510(k) Number: K050457
FDA product code: KTT
GMDN term: External orthopaedic fixation system, single-use

Device class: Class II
Regulation number: 888.3030
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

Other devices from Hnm Total Recon LLC

See all devices from Hnm Total Recon LLC →

Properties

Sterilise before use
Single use
Implantable
Lot / batch number
Manufacturing date

Other properties (10, all answered No)