Equinoxe 320-15-03

by Exactech, Inc.

Equinoxe 320-15-03 is a Class II device made by Exactech, Inc., cleared under FDA 510(k) K110708 on 1 Apr 2011 and listed in FDA GUDID since 30 Oct 2015 (UDI-DI 10885862186683), 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	Number10885862186683 UDI-DI	Date30 Oct 2015Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK110708	Date1 Apr 2011Decided	StatusActive

Official records

AccessGUDID record UDI-DI 10885862186683
FDA 510(k) database 510(k) number K110708

Across registries

2 registries list this device

FDA 510(k) K110708 decided 1 Apr 2011 Active
FDA GUDID UDI-DI 10885862186683 listed 30 Oct 2015 Listed

Timeline

2 dated events

1 Apr 2011 Cleared FDA 510(k) K110708
30 Oct 2015 Listed FDA GUDID 10885862186683

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Equinoxe
Generic name: Reverse shoulder prosthesis base plate
Model / Ref / Catalog: 320-15-03

Primary DI / UDI-DI: 10885862186683
510(k) Number: K110708
FDA product code: KWS, KWT
GMDN term: Reverse shoulder prosthesis base plate

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

Similar devices in this category

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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)