Invictus Bands System— 510(k) K253615
Substantially EquivalentAlphatec Spine, Inc.
FDA 510(k) clearance K253615 for Invictus Bands System, Substantially Equivalent on 2026-03-25. Applicant: Alphatec Spine, Inc.. Device class: 2.
Summary
Alphatec Spine's Invictus Bands System is filed under OWI, sublaminar bone fixation cerclage. The record doesn't list band sizes or components.
Class II, 21 CFR 888.3010. It was a Traditional 510(k), and Orthopedic is both the classification panel and the review panel.
Alphatec Spine filed from Carlsbad, California. The decision came 127 calendar days after FDA received it (November 18, 2025 to March 25, 2026).
Clearance details
- Applicant
- Alphatec Spine, Inc.
- Product code
- Product code OWI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3010
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
Recent devices under product code OWI
view allMore clearances from Alphatec Spine, Inc.
view all- K262646 — Calibrate MAX System +3 more
- K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System
- K253216 — IntraOp Alignment System; CONTOUR3D Bending System
- K252597 — Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)
- K252842 — SafeOp 3: Neural Informatix System
Data sourced from openFDA. This site is unofficial and independent of the FDA.