K242827
- 510(k) number
- K242827
- Device name
- A8 INTEGR8 Porous Pedicle Screws
- Applicant
- Allumin8, Inc. MO · US
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2025-10-20
- Date received
- 2024-09-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K242827.pdf
Official FDA record: K242827
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.