EXPert 03.010.504

EXPert 03.010.504 (03010504) is a Class II device made by Synthes, cleared under FDA 510(k) K070843 on 2 May 2007 and listed in FDA GUDID since 14 Sep 2015 (UDI-DI 10886982069214), 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	Number10886982069214 UDI-DI	Date14 Sep 2015Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK070843	Date2 May 2007Decided	StatusActive

Official records

AccessGUDID record UDI-DI 10886982069214
FDA 510(k) database 510(k) number K070843

Across registries

2 registries list this device

FDA 510(k) K070843 decided 2 May 2007 Active
FDA GUDID UDI-DI 10886982069214 listed 14 Sep 2015 Listed

Timeline

2 dated events

2 May 2007 Cleared FDA 510(k) K070843
14 Sep 2015 Listed FDA GUDID 10886982069214

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: EXPert
Generic name: Orthopaedic implantation sleeve, reusable
Model / Ref / Catalog: 03.010.504, 03010504

Primary DI / UDI-DI: 10886982069214
510(k) Number: K070843
FDA product code: HSB
GMDN term: Orthopaedic implantation sleeve, reusable

Device class: Class II
Regulation number: 888.3020
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

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Properties

Sterilise before use
Prescription use
Lot / batch number

Other properties (12, all answered No)