Equinoxe 301-05-01

by Exactech, Inc.

Equinoxe 301-05-01 is a Class II device made by Exactech, Inc., cleared under FDA 510(k) K061454 on 12 Jun 2006 and listed in FDA GUDID since 28 Jul 2022 (UDI-DI 10885862530479), 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	Number10885862530479 UDI-DI	Date28 Jul 2022Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK061454	Date12 Jun 2006Decided	StatusActive

Official records

AccessGUDID record UDI-DI 10885862530479
FDA 510(k) database 510(k) number K061454

Across registries

2 registries list this device

FDA 510(k) K061454 decided 12 Jun 2006 Active
FDA GUDID UDI-DI 10885862530479 listed 28 Jul 2022 Listed

Timeline

2 dated events

12 Jun 2006 Cleared FDA 510(k) K061454
28 Jul 2022 Listed FDA GUDID 10885862530479

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Equinoxe
Generic name: Surgical instrument handle, non-torque-limiting
Model / Ref / Catalog: 301-05-01

Primary DI / UDI-DI: 10885862530479
510(k) Number: K061454
FDA product code: HSD, KWS
GMDN term: Surgical instrument handle, non-torque-limiting

Device class: Class II
Regulation number: 888.3690, 888.3660
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

Other devices from Exactech, Inc.

See all devices from Exactech, Inc. →

Properties

Sterilise before use
Prescription use
Lot / batch number

Other properties (12, all answered No)