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Equinoxe 320-20-54

by Exactech, Inc.

Equinoxe 320-20-54 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 10885862186744), 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

510(k) K110708

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10885862186744 UDI-DI Date30 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK110708 Date1 Apr 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K110708 decided 1 Apr 2011 Active
  • FDA GUDID UDI-DI 10885862186744 listed 30 Oct 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K110708
  2. Listed FDA GUDID 10885862186744

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Equinoxe
Generic name
Shoulder prosthesis screw
Model / Ref / Catalog
320-20-54
Primary DI / UDI-DI
10885862186744
510(k) Number
FDA product code
KWS, KWT
GMDN term
Shoulder prosthesis screw
Device class
Class II
Regulation number
888.3660, 888.3650
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 4.5 Millimeter
Length — 54 Millimeter

Related devices

Category: Shoulder prosthesis screw

Cleared under the same submission (K110708)

and 8 more cleared under K110708

Similar devices in this category

Other devices filed under Shoulder prosthesis screw.

Other devices from Exactech, Inc.

See all devices from Exactech, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Serial number
  • Expiration date
Other properties (10, all answered No)