K223933
- 510(k) number
- K223933
- Device name
- Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws
- Applicant
- Exactech, Inc. FL · US
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2023-09-25
- Date received
- 2022-12-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K223933.pdf
Official FDA record: K223933
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.