K240526
- 510(k) number
- K240526
- Device name
- POWEReam Xia/Serrato
- Applicant
- Stryker Instruments MI · US
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2024-04-29
- Date received
- 2024-02-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K240526.pdf
Official FDA record: K240526
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.