Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System— 510(k) K261284
Substantially EquivalentAlphatec Spine, Inc.
FDA 510(k) clearance K261284 for Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System, Substantially Equivalent on 2026-07-14. Applicant: Alphatec Spine, Inc.. Device class: 2.
Summary
Alphatec Spine's clearance covers the Invictus Small Stature Spinal Fixation System and the Invictus 2.0 Spinal Fixation System, filed under NKB, thoracolumbosacral pedicle screw systems. The record doesn't list components.
Class II, 21 CFR 888.3070. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Alphatec Spine filed from Carlsbad, California. Review took 88 calendar days (April 17 to July 14, 2026).
Clearance details
- Applicant
- Alphatec Spine, Inc.
- Product code
- Product code NKB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3070
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
Recent devices under product code NKB
view allMore clearances from Alphatec Spine, Inc.
view all- K253216 — IntraOp Alignment System; CONTOUR3D Bending System
- K253615 — Invictus Bands System
- K252597 — Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)
- K252842 — SafeOp 3: Neural Informatix System
- K251965 — Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)
Adverse events under product code NKB
product code NKB- Death
- 27
- Injury
- 5,033
- Malfunction
- 4,140
- Total
- 9,200
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.