Tibial PCL Universal guide 255697

by Fournitures Hospitalieres Industrie

Tibial PCL Universal guide 255697 is a Class II device made by Fournitures Hospitalieres Industrie, cleared under FDA 510(k) K120740 on 5 Mar 2013 (1 earlier submission) and listed in FDA GUDID since 13 Mar 2019 (UDI-DI 03661489556975), 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

+1 more

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	Number03661489556975 UDI-DI	Date13 Mar 2019Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK120740	Date5 Mar 2013Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK113591	Date22 Dec 2011Decided	StatusActive

Official records

AccessGUDID record UDI-DI 03661489556975
FDA 510(k) database 510(k) number K120740
FDA 510(k) database 510(k) number K113591

Across registries

2 registries list this device

FDA 510(k) K120740 decided 5 Mar 2013 Active· +1 more in the status table
FDA GUDID UDI-DI 03661489556975 listed 13 Mar 2019 Listed

Timeline

3 dated events

22 Dec 2011 Cleared FDA 510(k) K113591
5 Mar 2013 Cleared FDA 510(k) K120740
13 Mar 2019 Listed FDA GUDID 03661489556975

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Tibial PCL Universal guide
Generic name: Orthopaedic prosthesis implantation positioning instrument, reusable
Model / reference: 255697

Primary DI / UDI-DI: 03661489556975
510(k) Number: K113591
K120740
FDA product code: HWC, MBI
GMDN term: Orthopaedic prosthesis implantation positioning instrument, reusable

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

Sterilisation method: Moist Heat or Steam Sterilization

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Properties

Sterilise before use
Lot / batch number
Manufacturing date

Other properties (12, all answered No)