Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
K2m, Inc. — Predicate Candidate Screening
100 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
231 days90th percentile
100clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260546 | Q Pedicle Instruments | K2m, Inc. | 2026-03-17 | 27 | 0 |
| K253545 | Vulcan Spinal System | K2m, Inc. | 2026-02-10 | 88 | 0 |
| K252873 | Q Interbody Instruments | K2m, Inc. | 2026-02-06 | 149 | 0 |
| K211320 | CAPRI Corpectomy Cage System | K2m, Inc. | 2022-02-24 | 300 | 0 |
| K202528 | Cannulated Power Driver Attachment | K2m, Inc. | 2020-10-26 | 55 | 0 |
| K201006 | K2M Navigation Instruments | K2m, Inc. | 2020-08-07 | 112 | 0 |
| K193203 | MOJAVE Expandable Interbody System | K2m, Inc. | 2020-02-18 | 90 | 0 |
| K193129 | Yukon OCT Spinal System | K2m, Inc. | 2020-02-07 | 87 | 0 |
| K192911 | Brainlab Compatible K2M Navigation Instruments | K2m, Inc. | 2019-11-14 | 30 | 0 |
| K190179 | SAHARA Stabilization System | K2m, Inc. | 2019-10-03 | 244 | 0 |
| K190584 | CAYMAN LP Plate System | K2m, Inc. | 2019-05-15 | 70 | 0 |
| K182473 | PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate Sy | K2m, Inc. | 2018-12-12 | 93 | 0 |
| K181603 | EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System | K2m, Inc. | 2018-10-05 | 108 | 0 |
| K180777 | K2M Expandable Interbody System | K2m, Inc. | 2018-08-03 | 130 | 0 |
| K181119 | Range (Denali and Mesa) Spinal Systems | K2m, Inc. | 2018-06-26 | 60 | 0 |
| K181188 | EVEREST Spinal System | K2m, Inc. | 2018-05-30 | 27 | 0 |
| K180376 | K2M Patient Specific Rods | K2m, Inc. | 2018-04-05 | 52 | 0 |
| K172009 | Cascadia Interbody System | K2m, Inc. | 2017-12-14 | 164 | 0 |
| K171832 | Range/Denali/Mesa Spinal System | K2m, Inc. | 2017-09-14 | 86 | 0 |
| K172104 | Ozark(tm) Cervical Plate System | K2m, Inc. | 2017-08-23 | 42 | 0 |
| K171444 | YUKON OCT Spinal System | K2m, Inc. | 2017-08-08 | 84 | 1 |
| K171097 | MOJAVE Expandable Interbody System | K2m, Inc. | 2017-05-10 | 27 | 0 |
| K161332 | NILE Proximal Fixation Spinal System | K2m, Inc. | 2017-04-05 | 328 | 0 |
| K162664 | Pyrenees Cervical Plate System | K2m, Inc. | 2016-10-07 | 11 | 0 |
| K162264 | Cascadia Interbody System | K2m, Inc. | 2016-09-21 | 41 | 0 |
| K161028 | K2M Growing Spine System | K2m, Inc. | 2016-07-22 | 101 | 0 |
| K160208 | NILE Alternative Fixation Spinal System | K2m, Inc. | 2016-03-18 | 50 | 0 |
| K151481 | Sahara Stabilization System | K2m, Inc. | 2015-12-21 | 202 | 0 |
| K151727 | Everest Spinal System | K2m, Inc. | 2015-09-17 | 83 | 0 |
| K152015 | Pyrenees Cervical Plate System | K2m, Inc. | 2015-09-04 | 45 | 0 |
| K150481 | Cascadia Interbody System | K2m, Inc. | 2015-08-20 | 177 | 0 |
| K151216 | Everest Spinal System | K2m, Inc. | 2015-08-10 | 96 | 0 |
| K142487 | Chesapeake Stabilization System | K2m, Inc. | 2015-05-07 | 245 | 0 |
| K142212 | Pyrenees Cervical Plate System | K2m, Inc. | 2015-05-01 | 262 | 0 |
| K150325 | Range/Denali/Mesa Spinal System | K2m, Inc. | 2015-03-31 | 50 | 0 |
| K143350 | Nile Alternative Fixation | K2m, Inc. | 2015-02-25 | 93 | 0 |
| K142360 | Everest Spinal System | K2m, Inc. | 2015-01-21 | 149 | 0 |
| K143334 | Range/Denali/Mesa Spinal System | K2m, Inc. | 2015-01-09 | 50 | 0 |
| K142016 | CAPRI | K2m, Inc. | 2014-11-06 | 104 | 0 |
| K141873 | RANGE/MESA/DENALI SPINAL SYSTEM | K2m, Inc. | 2014-09-08 | 59 | 0 |
| K133402 | K2M MODULAR HOOKS | K2m, Inc. | 2014-07-30 | 266 | 0 |
| K141284 | CASPIAN SPINAL SYSTEM | K2m, Inc. | 2014-07-23 | 68 | 0 |
| K140765 | RANGE/MESA/DENALI SPINAL SYSTEM | K2m, Inc. | 2014-07-10 | 105 | 0 |
| K133288 | CASPIAN OCT SPINAL SYSTEM | K2m, Inc. | 2014-07-01 | 249 | 0 |
| K133494 | CHESAPEAKE SPINAL SYSTEM | K2m, Inc. | 2014-06-10 | 208 | 0 |
| K141147 | RANGE SPINAL SYSTEM | K2m, Inc. | 2014-06-03 | 29 | 0 |
| K133614 | ALEUTIAN IBF SYSTEM | K2m, Inc. | 2014-04-03 | 129 | 0 |
| K133944 | RANGE, SPINAL SYSTEM, EVEREST SPINAL SYSTEM | K2m, Inc. | 2014-03-21 | 88 | 0 |
| K132757 | EVEREST SPINAL SYSTEM | K2m, Inc. | 2013-11-20 | 77 | 0 |
| K131533 | CAYMAN MI PLATE SYSTEM | K2m, Inc. | 2013-11-09 | 168 | 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