K232515
- 510(k) number
- K232515
- Device name
- Valkyrie Thoracic Fixation System
- Applicant
- Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices MI · US
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2023-12-08
- Date received
- 2023-08-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K232515.pdf
Official FDA record: K232515
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.