Product code ODP: 510(k) clearances and predicates
Product code ODP covers BluEX Cervical Expandable Cage System. FDA lists 354 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
354 clearances on file under product code ODP. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 12 |
| 2023 | 34 |
| 2024 | 10 |
| 2025 | 11 |
| 2026 so far | 19 |
Recent clearances
Newest ODP clearances in the FDA index, with applicant and decision date:
- K262595, VariLift-C Cervical Interbody Fusion System, applicant Wenzel Spine, Inc., decided 2026-08-26. FDA record
- K262489, BluEX Cervical Expandable Cage System, applicant L&K BIOMED Co., Ltd., decided 2026-08-18. FDA record
- K253041, 3d Cage Cervical, applicant Fims Co., Ltd., decided 2026-07-23. FDA record
- K262061, Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEM, applicant Stryker Spine, decided 2026-07-17. FDA record
- K254130, C.A. Medical Interbody Fusion System, applicant C.A. Medical, LLC, decided 2026-07-08. FDA record
- K260840, BluEX Cervical Expandable Cage System, applicant L&K BIOMED Co., Ltd., decided 2026-05-16. FDA record
- K260850, OSTEOMNI SPINAL CAGES SYSTEM, applicant Osteomni, Inc., decided 2026-05-12. FDA record
- K260549, ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System, applicant Zsfab, Inc., decided 2026-04-24. 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 VariLift-C Cervical Interbody Fusion System, 3d Cage Cervical. Watch new ODP 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 ODP?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent ODP clearances include BluEX Cervical Expandable Cage System.
How many 510(k) clearances use product code ODP?
354 at the time this page was generated, from openFDA records.
How do I find a predicate device under ODP?
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 ODP clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.