Cement Plug D111-16-0120

by Signature Orthopaedics Pty Ltd

Cement Plug D111-16-0120 is a Class II device made by Signature Orthopaedics Pty Ltd, cleared under FDA 510(k) K133370 on 22 Jul 2014 and listed in FDA GUDID since 20 Sep 2022 (UDI-DI 09348215053734), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number09348215053734 UDI-DI	Date20 Sep 2022Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK133370	Date22 Jul 2014Decided	StatusActive

Official records

AccessGUDID record UDI-DI 09348215053734
FDA 510(k) database 510(k) number K133370

Across registries

2 registries list this device

FDA 510(k) K133370 decided 22 Jul 2014 Active
FDA GUDID UDI-DI 09348215053734 listed 20 Sep 2022 Listed

Timeline

2 dated events

22 Jul 2014 Cleared FDA 510(k) K133370
20 Sep 2022 Listed FDA GUDID 09348215053734

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Cement Plug
Generic name: Polymer orthopaedic cement restrictor, non-bioabsorbable
Model / reference: D111-16-0120

Primary DI / UDI-DI: 09348215053734
510(k) Number: K133370
FDA product code: JDI
GMDN term: Polymer orthopaedic cement restrictor, non-bioabsorbable

Device class: Class II
Regulation number: 888.3350
GUDID distribution status: In Commercial Distribution

Other devices from Signature Orthopaedics Pty Ltd

See all devices from Signature Orthopaedics Pty Ltd →

Properties

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

Other properties (8, all answered No)