413.578E

413.578E (413578E) is a Class II device made by Synthes, cleared under FDA 510(k) K010943 on 27 Jun 2001 and listed in FDA GUDID since 14 Sep 2015 (UDI-DI 10887587048819), 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	Number10887587048819 UDI-DI	Date14 Sep 2015Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated	NumberK010943	Date27 Jun 2001Decided	StatusActive

Official records

AccessGUDID record UDI-DI 10887587048819
FDA 510(k) database 510(k) number K010943

Across registries

2 registries list this device

FDA 510(k) K010943 decided 27 Jun 2001 Active
FDA GUDID UDI-DI 10887587048819 listed 14 Sep 2015 Listed

Timeline

2 dated events

27 Jun 2001 Cleared FDA 510(k) K010943
14 Sep 2015 Listed FDA GUDID 10887587048819

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name: Sternal fixation device
Model / Ref / Catalog: 413.578E, 413578E

Primary DI / UDI-DI: 10887587048819
510(k) Number: K010943
FDA product code: HWC, JDQ, HRS
GMDN term: Sternal fixation device

Device class: Class II
Regulation number: 888.3040, 888.3010, 888.3030
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

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Properties

Sterilise before use
Single use
Implantable
Prescription use
Lot / batch number

Other properties (10, all answered No)