Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Spineology, Inc. — Predicate Candidate Screening
54 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
77 daysmedian FDA review time
212 days90th percentile
54clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251302 | OptiMesh Multiplanar Expandable Interbody Fusion System | Spineology, Inc. | 2025-12-15 | 231 | 0 |
| K251943 | Spineology Navigation Instruments | Spineology, Inc. | 2025-12-04 | 163 | 0 |
| K230927 | OptiMesh Multiplanar Expandable Interbody Fusion System | Spineology, Inc. | 2023-11-01 | 212 | 0 |
| K231781 | OptiMesh Multiplanar Expandable Interbody Fusion System | Spineology, Inc. | 2023-10-18 | 124 | 0 |
| K213876 | Spineology Navigation Instruments | Spineology, Inc. | 2022-08-05 | 235 | 0 |
| K210155 | Duo Expandable Interbody Fusion System | Spineology, Inc. | 2021-02-19 | 29 | 0 |
| DEN200010 | Spineology Interbody Fusion System | Spineology, Inc. | 2020-09-18 | 212 | 0 |
| K192047 | Rampart™ One Lumbar Interbody Fusion System | Spineology, Inc. | 2019-08-23 | 23 | 0 |
| K191091 | Rampart One Lumbar Interbody Fusion System | Spineology, Inc. | 2019-05-23 | 29 | 0 |
| K190055 | Duo Lumbar Interbody Fusion Device | Spineology, Inc. | 2019-03-07 | 55 | 0 |
| K182322 | Duo Lumbar Interbody Fusion Device | Spineology, Inc. | 2018-10-24 | 58 | 0 |
| K182345 | Spineology Navigation Instruments | Spineology, Inc. | 2018-09-21 | 24 | 0 |
| K181792 | Duo™ Lumbar Interbody Fusion Device | Spineology, Inc. | 2018-08-14 | 40 | 0 |
| K180796 | Spineology Navigation Instruments | Spineology, Inc. | 2018-05-02 | 36 | 0 |
| K180002 | Rampart One Lumbar Interbody Fusion Device | Spineology, Inc. | 2018-04-25 | 113 | 0 |
| K172518 | Spineology Navigation Instruments | Spineology, Inc. | 2018-01-05 | 137 | 0 |
| K172107 | Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicula | Spineology, Inc. | 2017-08-21 | 40 | 0 |
| K171660 | Duo Lumbar Interbody Fusion Device | Spineology, Inc. | 2017-08-18 | 74 | 0 |
| K171724 | Rampart L Lumbar Interbody Fusion Device | Spineology, Inc. | 2017-07-24 | 42 | 0 |
| K171438 | Palisade™ Pedicular Fixation System | Spineology, Inc. | 2017-06-02 | 17 | 0 |
| K163670 | Rampart One Lumbar Interbody Fusion Device | Spineology, Inc. | 2017-05-08 | 132 | 0 |
| K170268 | Fortress™ Pedicular Fixation System | Spineology, Inc. | 2017-04-14 | 77 | 0 |
| K170255 | Threshold™ V2 Pedicular Fixation System | Spineology, Inc. | 2017-04-14 | 77 | 0 |
| K170266 | Palisade™ Pedicular Fixation System | Spineology, Inc. | 2017-04-14 | 77 | 0 |
| K170251 | Threshold™ Pedicular Fixation System | Spineology, Inc. | 2017-04-14 | 77 | 0 |
| K163409 | Rampart(TM) T Lumbar Interbody Fusion Device | Spineology, Inc. | 2017-03-08 | 93 | 0 |
| K162879 | Elite Expandable Interbody Fusion Device | Spineology, Inc. | 2017-01-30 | 108 | 0 |
| K160074 | Rampart D Lumbar Interbody Fusion Device | Spineology, Inc. | 2016-10-18 | 278 | 0 |
| K161694 | Threshold™ Pedicular Fixation System | Spineology, Inc. | 2016-07-15 | 25 | 0 |
| K160906 | Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar I | Spineology, Inc. | 2016-07-14 | 104 | 0 |
| K160980 | Threshold Pedicular Fixation System, Palisade Pedicular Fixa | Spineology, Inc. | 2016-05-26 | 49 | 0 |
| K153323 | Palisade Pedicular Fixation System | Spineology, Inc. | 2016-02-23 | 97 | 0 |
| K153082 | Rampart A Lumbar Interbody Fusion Device | Spineology, Inc. | 2016-02-04 | 104 | 0 |
| K152148 | Fortress Pedicular Fixation System | Spineology, Inc. | 2015-09-02 | 30 | 0 |
| K151020 | Rampart-T Interbody Fusion System | Spineology, Inc. | 2015-07-22 | 97 | 0 |
| K143403 | Threshold Pedicular Fixation System | Spineology, Inc. | 2014-12-18 | 20 | 0 |
| K142213 | VIA SPINOUS PROCESS FIXATION SYSTEM | Spineology, Inc. | 2014-09-10 | 29 | 0 |
| K140010 | FORTRESS PEDICLE SCREW SYSTEM | Spineology, Inc. | 2014-04-23 | 111 | 0 |
| K133371 | RAMPART-L | Spineology, Inc. | 2014-01-09 | 69 | 0 |
| K132053 | RAMPART-O, RAMPART-T | Spineology, Inc. | 2013-09-16 | 75 | 0 |
| K131216 | RAMPART O | Spineology, Inc. | 2013-05-30 | 30 | 0 |
| K130396 | RAMPART O AND RAMPART P | Spineology, Inc. | 2013-03-25 | 34 | 0 |
| K123652 | SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE | Spineology, Inc. | 2013-03-22 | 115 | 0 |
| K123232 | SPINEOLOGY SPINOUS PROCESS PLATE | Spineology, Inc. | 2013-02-07 | 114 | 0 |
| K121129 | SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE | Spineology, Inc. | 2012-06-13 | 61 | 0 |
| K120293 | SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DRIVE | Spineology, Inc. | 2012-02-29 | 29 | 0 |
| K113030 | SPINEOLOGY PEEK BULLET LUMBAR INTERBODY FUSION DEVICE | Spineology, Inc. | 2012-01-26 | 106 | 0 |
| K111880 | SPINEOLGY PEEK BULLET LUMBER INTERBODY FUSION DEVICE | Spineology, Inc. | 2011-09-26 | 87 | 0 |
| K110933 | SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE | Spineology, Inc. | 2011-06-13 | 70 | 0 |
| K092464 | SPINEOLOGY FACET SCREW | Spineology, Inc. | 2009-11-09 | 90 | 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