FDA.report

510(k) K260583

Device
Equinoxe® Shoulder System
Applicant
Exactech, Inc.
510(k) number
K260583
Product code
PHX
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-14
Date received
2026-02-20
Regulation
888.3660
Classification name
Shoulder Prosthesis, Reverse Configuration
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Pedro Ravelo
Address
2320 NW 66th Ct. Gainesville FL US 32653 32653

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code PHX

510(k)DeviceApplicantDecision date
K253992Veritas Reverse Total Shoulder SystemRestor3D2026-05-07
K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics2026-04-15
K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.2026-04-13
K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)2026-04-03
K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC2026-03-11
K250644MSS - Monobloc stemMedacta International S.A.2026-02-03
K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.2026-01-22
K252567AltiVate Reverse® ADLC GlenosphereEncore Medical L.P.2026-01-15
K252516N22 EZ GlenosphereShoulder Innovations, Inc.2026-01-15
K254003JARVIS Metaphyseal StemFH Industrie2026-01-09
K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.2026-01-08
K250338MSS - Humeral reverse liners extensionMedacta International S.A.2025-10-31
K253345JARVIS Diaphyseal Stem StandardFH Industrie2025-10-29
K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.2025-09-26
K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie2025-08-28