Orthex Half Pin HPP30-150-10B

by Vilex in Tennessee, Inc.

Orthex Half Pin HPP30-150-10B is a Class II device made by Vilex in Tennessee, Inc., cleared under FDA 510(k) K132820 on 23 Jul 2014 and listed in FDA GUDID since 22 Aug 2016 (UDI-DI 00841731109552), 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	Number00841731109552 UDI-DI	Date22 Aug 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK132820	Date23 Jul 2014Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00841731109552
FDA 510(k) database 510(k) number K132820

Across registries

2 registries list this device

FDA 510(k) K132820 decided 23 Jul 2014 Active
FDA GUDID UDI-DI 00841731109552 listed 22 Aug 2016 Listed

Timeline

2 dated events

23 Jul 2014 Cleared FDA 510(k) K132820
22 Aug 2016 Listed FDA GUDID 00841731109552

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Orthex Half Pin
Generic name: External orthopaedic fixation system, single-use, sterile
Model / reference: HPP30-150-10B

Primary DI / UDI-DI: 00841731109552
510(k) Number: K132820
FDA product code: JDW
GMDN term: External orthopaedic fixation system, single-use, sterile

Device class: Class II
Regulation number: 888.3040
GUDID distribution status: In Commercial Distribution

Other devices from Vilex in Tennessee, Inc.

See all devices from Vilex in Tennessee, Inc. →

Properties

Supplied sterile
Single use
Prescription use
Lot / batch number
Expiration date

Other properties (10, all answered No)