Skip to content

Exactech Equinoxe Shoulder Stems

by Exactech, Inc.

510(k) K061454

Exactech Equinoxe Shoulder Stems is a Class II device made by Exactech, Inc., cleared under FDA 510(k) K061454 on 12 Jun 2006, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK061454 Date12 Jun 2006ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
HSD
Device class
Class II
Regulation
21 CFR Part 888.3690
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Other devices from Exactech, Inc.

See all devices from Exactech, Inc. →