E01-000

by Orthoxel Designated Activity Company

E01-000 is a Class II device made by Orthoxel Designated Activity Company, cleared under FDA 510(k) K170972 on 20 Dec 2017 and listed in FDA GUDID since 6 Jun 2019 (UDI-DI 05391529580766), 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	Number05391529580766 UDI-DI	Date6 Jun 2019Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k) from GUDID	NumberK170972	Date20 Dec 2017Issued	StatusActive

Official records

AccessGUDID record UDI-DI 05391529580766
FDA 510(k) database 510(k) number K170972

Across registries

2 registries list this device

FDA 510(k) K170972 decided 20 Dec 2017 Active
FDA GUDID UDI-DI 05391529580766 listed 6 Jun 2019 Listed

Timeline

2 dated events

20 Dec 2017 Cleared FDA 510(k) K170972
6 Jun 2019 Listed FDA GUDID 05391529580766

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name: Bone nail implantable cap
Model / Ref / Catalog: E01-000

Primary DI / UDI-DI: 05391529580766
510(k) Number: K170972
FDA product code: HWC
GMDN term: Bone nail implantable cap

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

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Properties

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

Other properties (9, all answered No)