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Equinoxe 309-12-05

by Exactech, Inc.

Equinoxe 309-12-05 is a Class I device made by Exactech, Inc., listed in FDA GUDID since 19 Sep 2022 (UDI-DI 10885862267757), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10885862267757 UDI-DI Date19 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Equinoxe
Generic name
Humeral stem prosthesis trial, reusable
Model / Ref / Catalog
309-12-05
Primary DI / UDI-DI
10885862267757
FDA product code
HWT
GMDN term
Humeral stem prosthesis trial, reusable
Device class
Class I
Regulation number
888.4800
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Height — 12.5 Millimeter

Related devices

Category: Humeral stem prosthesis trial, reusable

Other devices from Exactech, Inc.

See all devices from Exactech, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (11, all answered No)