Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NQW — Predicate Candidate Screening
30 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
189 days90th percentile
30clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252930 | AQUA Laminoplasty Systems | ZheJiang Decans Medical Devices Co., Ltd. | 2026-05-27 | 254 | 0 |
| K243137 | Curiteva Porous PEEK Laminoplasty System | Curiteva, Inc. | 2024-10-28 | 28 | 0 |
| K242784 | Vy Spine™ VyLam™ Laminoplasty System | Vy Spine, LLC | 2024-10-16 | 30 | 0 |
| K232471 | Vy Spine™ VyLam™ Laminoplasty System | Vy Spine, LLC | 2023-10-10 | 55 | 0 |
| K231232 | Curiteva Laminoplasty System | Curiteva, Inc. | 2023-06-28 | 61 | 0 |
| K212428 | Centerpiece Plate Fixation System | Medtronic Sofamor Danek | 2021-12-13 | 131 | 0 |
| K191927 | Hinged Laminoplasty System | Life Spine, Inc. | 2019-09-20 | 63 | 0 |
| K191169 | NuVasive® Camber Laminoplasty System | Nu Vasive, Incorporated | 2019-07-03 | 63 | 0 |
| K181717 | Life Spine Laminoplasty System | Life Spine, Inc. | 2018-10-12 | 106 | 0 |
| K173215 | Choice Spine Laminoplasty™ Fixation System | Choicespine, LP | 2018-01-19 | 109 | 0 |
| K171413 | HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation Sy | Globus Medical, Inc. | 2017-07-14 | 60 | 0 |
| K160114 | Xspan Laminoplasty Fixation System | X-Spine Systems, Inc. | 2016-03-15 | 56 | 0 |
| K153735 | Release Laminoplasty Fixation System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2016-01-21 | 24 | 0 |
| K150469 | Integra Laminoplasty System | Seaspine, Inc. | 2015-03-23 | 28 | 0 |
| K132740 | SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYST | Spinefrontier, Inc. | 2013-11-26 | 84 | 0 |
| K130830 | INTEGRA LAMINOPLASTY SYSTEM | Seaspine, Inc. | 2013-05-09 | 44 | 0 |
| K122822 | SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEM | Spectrum Spine, LLC | 2013-02-07 | 146 | 0 |
| K121732 | CANOPY LAMINOPLASTY FIXATION SYSTEM | Globus Medical, Inc. | 2012-10-31 | 140 | 0 |
| K121276 | NEURO VENTION LAMINPLASTY PLATING SYSTEM | Neurovention, LLC | 2012-08-29 | 124 | 0 |
| K113802 | ESCALATE LAMINOPLASTY SYSTEM | Stryker Spine | 2012-04-16 | 115 | 0 |
| K113218 | PIONEER RELEASE LAMINOPLASTY PLATING SYSTEM | Pioneer Surgical Technology, Inc. | 2012-01-26 | 86 | 0 |
| K103284 | LAMINOPLASY PLATING SYSTEM | Aesculap Implant Systems, Inc. | 2010-12-02 | 27 | 0 |
| K100805 | GALLERY LAMINOPLASTY FIXATION SYSTEM | Biomet Spine (Aka Ebi, LLC) | 2010-07-20 | 120 | 0 |
| K091994 | MOUNTAINEER LAMINOPLASTY SYSTEM | Depuy Spine, Inc. | 2010-01-07 | 189 | 0 |
| K091623 | LAMINOPLASTY FIXATION SYSTEM | Nuvasive, Inc. | 2009-10-09 | 128 | 0 |
| K090354 | LAMINOPLASTY PLATING SYSTEM | Aesculap Implant System, Inc. | 2009-05-12 | 90 | 0 |
| K080664 | RELIEVE LAMINOPLASTY FIXATION SYSTEM | Globus Medical, Inc. | 2008-07-25 | 137 | 0 |
| K050082 | CENTERPIECE PLATE FIXATION SYSTEM | Medtronic Sofamor Danek, Inc. | 2005-06-06 | 144 | 0 |
| K043338 | BLAKSTONE LAMINOPLASTY FIXATION SYSTEM | Blackstone Medical, Inc. | 2005-02-18 | 77 | 0 |
| K032534 | SYNTHES AFS | Synthes Spine | 2004-04-01 | 230 | 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