Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Spine Wave, Inc. · Predicate Candidate Screening
59 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
83 daysmedian FDA review time
206 days90th percentile
59clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260286 | Dynamo™ Spinal Cement; Salvo® Spine System | Spine Wave, Inc. | 2026-06-15 | 137 | 0 |
| K261159 | Exceed® Biplanar Expandable Interbody System | Spine Wave, Inc. | 2026-05-29 | 51 | 0 |
| K243816 | Testa TP Pivoting Spacer System | Spine Wave, Inc. | 2025-06-27 | 197 | 0 |
| K251131 | Annex® 2 Adjacent Level System | Spine Wave, Inc. | 2025-06-06 | 56 | 0 |
| K243514 | Salvo® Robotic Navigation Instruments | Spine Wave, Inc. | 2025-04-03 | 141 | 0 |
| K240685 | Salvo® Spine System | Spine Wave, Inc. | 2024-05-06 | 55 | 0 |
| K231275 | Exceed™ Biplanar Expandable Interbody System | Spine Wave, Inc. | 2023-07-25 | 84 | 0 |
| K222362 | Salvo® Spine System | Spine Wave, Inc. | 2022-08-29 | 25 | 0 |
| K202476 | Salvo® Spine System | Spine Wave, Inc. | 2020-11-05 | 69 | 0 |
| K192526 | Spine Wave Navigated Instruments | Spine Wave, Inc. | 2019-10-10 | 27 | 0 |
| K191045 | Salvo™ Spine System | Spine Wave, Inc. | 2019-07-10 | 82 | 0 |
| K182954 | Salvo™ Spine System | Spine Wave, Inc. | 2018-12-12 | 49 | 0 |
| K181596 | Spine Wave Navigated Instruments | Spine Wave, Inc. | 2018-10-24 | 128 | 0 |
| K181440 | Proficient® Posterior Cervical Spine System | Spine Wave, Inc. | 2018-07-30 | 59 | 0 |
| K172594 | Proficient® Posterior Cervical Spine System | Spine Wave, Inc. | 2017-12-15 | 108 | 0 |
| K173175 | Paramount Anterior Cervical Cage System | Spine Wave, Inc. | 2017-11-01 | 33 | 0 |
| K172175 | CapSure® PS System | Spine Wave, Inc. | 2017-08-16 | 28 | 0 |
| K163246 | Leva Anterior Expandable Spacer System | Spine Wave, Inc. | 2017-04-06 | 139 | 0 |
| K162760 | Spine Wave Anterior Cervical Spine System | Spine Wave, Inc. | 2017-02-16 | 139 | 0 |
| K162639 | Proficient™ Posterior Cervical Spine System | Spine Wave, Inc. | 2017-02-07 | 138 | 0 |
| K161993 | Leva® Anterior Interbody System | Spine Wave, Inc. | 2016-11-22 | 126 | 0 |
| K153222 | Leva Spacer System | Spine Wave, Inc. | 2016-04-15 | 161 | 0 |
| K160003 | Sniper (R) Spine System | Spine Wave, Inc. | 2016-02-26 | 53 | 0 |
| K152620 | Spine Wave Gen II Expandable Interbody System | Spine Wave, Inc. | 2016-01-15 | 123 | 0 |
| K152174 | Sniper Spine System | Spine Wave, Inc. | 2015-08-31 | 27 | 0 |
| K151813 | Sniper Spine System | Spine Wave, Inc. | 2015-07-31 | 29 | 0 |
| K151581 | Leva Spacer System | Spine Wave, Inc. | 2015-07-09 | 28 | 0 |
| K150285 | Leva(TM) Spacer System | Spine Wave, Inc. | 2015-03-05 | 28 | 0 |
| K142996 | StaXx(R) XD System | Spine Wave, Inc. | 2015-02-19 | 126 | 0 |
| K141980 | LEVA (TM) SPACER SYSTEM | Spine Wave, Inc. | 2015-01-26 | 189 | 0 |
| K142980 | Proficient (TM) Facet Screw Spine System | Spine Wave, Inc. | 2015-01-16 | 93 | 0 |
| K142101 | ABACUS (TM) SPACER SYSTEM | Spine Wave, Inc. | 2014-10-23 | 83 | 0 |
| K140007 | ABACUS TM SPACER SYSTEM | Spine Wave, Inc. | 2014-04-07 | 95 | 0 |
| K132403 | ANNEXTM ADJACENT LEVEL SYSTEM | Spine Wave, Inc. | 2014-01-10 | 162 | 0 |
| K133207 | STAXX(R) SYSTEM | Spine Wave, Inc. | 2013-12-06 | 49 | 0 |
| K132719 | STAXX IBL SYSTEM | Spine Wave, Inc. | 2013-10-04 | 35 | 0 |
| K131071 | STAXX IBL SYSTEM | Spine Wave, Inc. | 2013-08-20 | 125 | 0 |
| K132154 | CAPSURE PS SYSTEM | Spine Wave, Inc. | 2013-08-09 | 28 | 0 |
| K123461 | STAXX(R) IB SYSTEM | Spine Wave, Inc. | 2013-04-11 | 153 | 1 |
| K122233 | CAPSURE(R) PS SYSTEM | Spine Wave, Inc. | 2012-10-11 | 77 | 0 |
| K121889 | STAXX XD SYSTEM | Spine Wave, Inc. | 2012-08-29 | 62 | 0 |
| K120646 | CAPSURE(R) PS SYSTEM | Spine Wave, Inc. | 2012-06-07 | 97 | 0 |
| K111418 | STAXX(R) XD SYSTEM | Spine Wave, Inc. | 2011-12-13 | 207 | 0 |
| K111913 | CAPSURE(R) PS SYSTEM | Spine Wave, Inc. | 2011-08-31 | 56 | 0 |
| K102315 | STAXX XDL SYSTEM | Spine Wave, Inc. | 2011-08-19 | 368 | 0 |
| K111469 | STAXXSD SYSTEM | Spine Wave, Inc. | 2011-07-19 | 53 | 0 |
| K102682 | STAXX(R) XD SYSTEM | Spine Wave, Inc. | 2010-11-30 | 74 | 0 |
| K101288 | STAXX XD SYSTEM | Spine Wave, Inc. | 2010-09-10 | 126 | 1 |
| K100605 | MIS SYSTEM | Spine Wave, Inc. | 2010-06-04 | 93 | 0 |
| K100122 | MODIFICATION TO CAPSURE PS SYSTEM | Spine Wave, Inc. | 2010-02-12 | 28 | 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