K233154
- 510(k) number
- K233154
- Device name
- SkyOPS Orthopedic Plate System
- Applicant
- Sky Surgical, LLC ID · US
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2023-12-21
- Date received
- 2023-09-27
- 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: K233154.pdf
Official FDA record: K233154
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.