K243275
- 510(k) number
- K243275
- Device name
- Equinoxe® Scapula Fracture System
- Applicant
- Exactech, Inc. FL · US
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2025-06-26
- Date received
- 2024-10-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K243275.pdf
Official FDA record: K243275
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.