Product code NKB: 510(k) clearances and predicates
Product code NKB covers Kentrospine Viktr-MIS® Pedicle screw system. FDA lists 910 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
910 clearances on file under product code NKB. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 34 |
| 2023 | 44 |
| 2024 | 39 |
| 2025 | 24 |
| 2026 so far | 26 |
Recent clearances
Newest NKB clearances in the FDA index, with applicant and decision date:
- K252139, Kentrospine Viktr-MIS® Pedicle screw system, applicant Rivarp Medical Pvt., Ltd., decided 2026-09-27. FDA record
- K262067, iFuse Granite Onyx Implant System, applicant SI-BONE, Inc., decided 2026-09-23. FDA record
- K262091, FRAXION Spinal Fixation System, applicant Ortler Global Tibbi Gerecler Anonim Sirketi, decided 2026-09-17. FDA record
- K262193, RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology, applicant Xenix Medical, decided 2026-09-14. FDA record
- K262828, KHEIRON® Spinal Fixation System, including patient specific K-ROD, applicant S.M.A.I.O, decided 2026-09-04. FDA record
- K253943, Tiger 2 System, applicant Zavation Medical Products, LLC, decided 2026-07-24. FDA record
- K260362, QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration), applicant MANTIZ Co., Ltd., decided 2026-07-24. FDA record
- K261284, Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System, applicant Alphatec Spine, Inc., decided 2026-07-14. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include iFuse Granite Onyx Implant System, FRAXION Spinal Fixation System. Watch new NKB clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code NKB?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent NKB clearances include Kentrospine Viktr-MIS® Pedicle screw system.
How many 510(k) clearances use product code NKB?
910 at the time this page was generated, from openFDA records.
How do I find a predicate device under NKB?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new NKB clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.