Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OVE — Predicate Candidate Screening
165 FDA 510(k) clearances under this product code; the 50 most recent screened below.
119 daysmedian FDA review time
250 days90th percentile
165clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261451 | ZSAlign Cervical Interbody System | ZSFab, Inc. | 2026-07-31 | 91 | 0 |
| K262094 | E3D™-C Interbody System | Evolution Spine | 2026-07-22 | 30 | 0 |
| K261279 | DeltaNEC Interbody System | Nexus Spine | 2026-06-22 | 66 | 0 |
| K252982 | CONDUIT™ ZERO-P™ VA Secured Spacer System | Avalign Technologies, Inc. | 2026-06-18 | 274 | 0 |
| K260036 | NeckTune™ 3D SA Cervical Cage | Medyssey Co, Ltd. | 2026-06-15 | 160 | 0 |
| K260660 | SABER-C System | Elevation Spine | 2026-04-27 | 56 | 0 |
| K253213 | SAGI Cervical Cage System | ZheJiang Decans Medical Devices Co., Ltd. | 2026-04-20 | 203 | 0 |
| K252774 | Uni-C Cervical Cage System | ZheJiang Decans Medical Devices Co., Ltd. | 2026-04-15 | 225 | 0 |
| K260038 | E3D™-C Interbody System | Evolution Spine | 2026-02-04 | 29 | 0 |
| K253876 | HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) | Globus Medical, Inc. | 2025-12-22 | 18 | 0 |
| K253200 | Cervical Spine Truss System - Stand Alone (CSTS-SA) | 4Web Medical, Inc. | 2025-12-11 | 76 | 0 |
| K250076 | Endeavor™ Stand-Alone Cervical IBF System | Innovasis | 2025-09-25 | 258 | 0 |
| K250540 | SABER-C System | Elevation Spine | 2025-08-08 | 165 | 0 |
| K251735 | Stabilis SA Cervical Stand-Alone System (Various PNs) | Acuity Surgical Devices, LLC | 2025-07-30 | 54 | 0 |
| K251431 | FIX-C PEEK ACIF SA System | Jeil Medical Corporation | 2025-06-27 | 50 | 0 |
| K251117 | Cervical Spine Truss System (CSTS) | 4Web Medical | 2025-04-25 | 14 | 0 |
| K242928 | Tesera-k SC System | Kyocera Medical Technologies, Inc. | 2025-04-10 | 198 | 0 |
| K243188 | CYLOX® ST | Signus Medizintechnik GmbH | 2025-02-11 | 134 | 0 |
| K242483 | Genesys Spine AIS-C II Cervical Interbody Fusion System | Genesys Spine | 2025-02-07 | 170 | 0 |
| K242517 | ProAM ACDF System | Pro Surgical, Inc. | 2024-11-20 | 89 | 0 |
| K241846 | E3D™-C Interbody System | Evolution Spine | 2024-08-12 | 47 | 0 |
| K241467 | Stable-C Interbody System | Nexus Spine, LLC | 2024-07-17 | 55 | 0 |
| K240699 | SCARLET® AC-Ti | Spineart SA | 2024-05-10 | 57 | 0 |
| K234119 | UniSpace® Stand-Alone C Cage | Innosys Co., Ltd. | 2024-04-19 | 113 | 0 |
| K240715 | Idys® C ZP 3DTi | Clariance | 2024-03-22 | 7 | 0 |
| K233594 | Genesys Spine 3DP AIS-C II Cervical Interbody System | Genesys Spine | 2023-12-13 | 35 | 0 |
| K233414 | Shoreline ACS Interbody System; Shoreline RT Interbody Syste | SeaSpine Orthopedics Corporation | 2023-11-28 | 49 | 0 |
| K233191 | TotalTi ACDF by SAGICO | Spinal Analytics & Geometrical Implant Co, LLC | 2023-11-21 | 54 | 0 |
| K232348 | RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion Sys | MiRus, LLC | 2023-10-27 | 81 | 0 |
| K231704 | Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System | Life Spine, Inc. | 2023-10-19 | 129 | 0 |
| K231739 | Cervical Spine Truss System (CSTS) | 4Web Medical, Inc. | 2023-09-25 | 103 | 0 |
| K223869 | ChoiceSpine Blackhawk Ti Cervical Spacer System | Choice Spine, LLC | 2023-09-14 | 265 | 0 |
| K231763 | Stable-C Interbody System | Nexus Spine, LLC | 2023-08-21 | 66 | 0 |
| K230608 | SPICCA Stand-Alone Cervical Fusion Cages | Southern Medical (Pty) , Ltd. | 2023-08-14 | 164 | 0 |
| K221138 | Titus Titanium Cervical by SAGICO | Sagico VA USA, LLC | 2023-08-04 | 472 | 0 |
| K231808 | QUASAR Standalone ACIF System | GS Medical Co., Ltd. | 2023-07-20 | 30 | 0 |
| K223143 | SAGICO Spinal System | Sagico VA USA, LLC | 2023-06-26 | 265 | 0 |
| K223059 | Xenco Medical InterAlign Cervical Interbody System | Xenco Medical, LLC | 2023-06-07 | 250 | 0 |
| K223837 | SPIRA®-C Integrated Fixation System | Camber Spine Technologies | 2023-03-22 | 90 | 0 |
| K222041 | CYGNUS-C Standalone ACIF System | GS Medical Co., Ltd. | 2023-02-09 | 213 | 0 |
| K223362 | Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbod | 4Web Medical, Inc. | 2023-02-02 | 91 | 0 |
| K223105 | Tesera-K SC System | Kyocera Medical Technologies, Inc. | 2022-12-22 | 83 | 0 |
| K223140 | AEON-C™ Stand Alone System | Dio Medical, Inc. | 2022-12-20 | 77 | 0 |
| K223190 | Hive™ Standalone Cervical System | NanoHive Medical, LLC | 2022-12-12 | 60 | 0 |
| K222903 | Tailored-H Cervical Stand Alone System | Bespoke Technologies, LLC | 2022-11-18 | 56 | 0 |
| K212612 | Omnia Medical TiBrid-SC | Omnia Medical, LLC | 2022-11-15 | 455 | 0 |
| K221578 | Hexanium ACIF | Spinevision, S.A.S. | 2022-11-14 | 166 | 0 |
| K221049 | Zavation VariSync Plate System and VariSync Spacer System | Zavation Medical Products, LLC | 2022-08-12 | 123 | 0 |
| K213791 | Unispace SA Cervical Cage | Edisoninno Co., Ltd. | 2022-08-05 | 242 | 0 |
| K211417 | F3D-C2 Cervical Stand-Alone System | Corelink, LLC | 2022-02-04 | 273 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda