Equinoxe 300-51-00

by Exactech, Inc.

Equinoxe 300-51-00 is a Class II device made by Exactech, Inc., cleared under FDA 510(k) K121067 on 6 Dec 2012 and listed in FDA GUDID since 30 Oct 2015 (UDI-DI 10885862217998), 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	Number10885862217998 UDI-DI	Date30 Oct 2015Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK121067	Date6 Dec 2012Decided	StatusActive

Official records

AccessGUDID record UDI-DI 10885862217998
FDA 510(k) database 510(k) number K121067

Across registries

2 registries list this device

FDA 510(k) K121067 decided 6 Dec 2012 Active
FDA GUDID UDI-DI 10885862217998 listed 30 Oct 2015 Listed

Timeline

2 dated events

6 Dec 2012 Cleared FDA 510(k) K121067
30 Oct 2015 Listed FDA GUDID 10885862217998

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Equinoxe
Generic name: Shoulder humeral body prosthesis
Model / Ref / Catalog: 300-51-00

Primary DI / UDI-DI: 10885862217998
510(k) Number: K121067
FDA product code: HSD, KWT, KWS
GMDN term: Shoulder humeral body prosthesis

Device class: Class II
Regulation number: 888.3690, 888.3650, 888.3660
GUDID distribution status: In Commercial Distribution

Similar devices in this category

Other devices filed under Shoulder humeral body prosthesis.

Other devices from Exactech, Inc.

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Properties

Supplied sterile
Single use
Implantable
Prescription use
Serial number
Expiration date

Other properties (9, all answered No)