K261284
- 510(k) number
- K261284
- Device name
- Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System
- Applicant
- Alphatec Spine, Inc. CA · US
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2026-07-14
- Date received
- 2026-04-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K261284.pdf
Official FDA record: K261284
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.