Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Nexxt Spine, LLC — Predicate Candidate Screening

22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

62 daysmedian FDA review time
131 days90th percentile
22clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC2023-07-20300
K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC2022-07-28280
K220291NEXXT SPINE NAVIGATION SystemNexxt Spine, LLC2022-03-31580
K202230NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC2020-12-151300
K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC2020-09-17430
K200969NEXXT MATRIXX SystemNexxt Spine, LLC2020-05-21380
K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC2020-03-23200
K193412NEXXT MATRIXX SystemNexxt Spine, LLC2020-02-24770
K193370Nexxt Matrixx SystemNexxt Spine, LLC2020-01-21470
K192687TrellOss™-L MPFNexxt Spine, LLC2020-01-091050
K191408Nexxt Matrixx SystemNexxt Spine, LLC2019-07-10430
K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC2019-05-31870
K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC2018-11-13620
K171140Matrixx SystemNexxt Spine, LLC2017-08-221260
K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC2016-04-261480
K141376INERTIA PEDICLE SCREW SYSTEM, HONOUR SPACER SYSTEM, FACET FINexxt Spine, LLC2014-06-26300
K133475STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWSNexxt Spine, LLC2013-12-19370
K132412INERTIA MIS PEDICLE SCREW SYSTEMNexxt Spine, LLC2013-10-10690
K131417FACET FIXXNexxt Spine, LLC2013-07-12570
K120345HONOUR SPACER SYSTEMNexxt Spine, LLC2012-06-131310
K101278INERTIA PEDICLE SCREW SYSTEMNexxt Spine, LLC2010-12-202280
K090984INERTIA PEDICLE SCREW SYSTEMNexxt Spine, LLC2009-06-30840

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