Atlas FDA

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

Nexus Spine, LLC · Predicate Candidate Screening

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

96 daysmedian FDA review time
170 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC2025-04-301310
K241467Stable-C Interbody SystemNexus Spine, LLC2024-07-17550
K233375Tranquil-L Interbody SystemNexus Spine, LLC2024-03-201700
K240416Tranquil-C Interbody SystemNexus Spine, LLC2024-03-12290
K233234PressON Spinal Fixation SystemNexus Spine, LLC2023-10-26280
K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC2023-10-121420
K232530Stable-L Standalone Lumbar Interbody System, Stable-C InterbNexus Spine, LLC2023-09-18280
K231763Stable-C Interbody SystemNexus Spine, LLC2023-08-21660
K223529PressON Spinal Fixation SystemNexus Spine, LLC2023-05-021600
K223627PreView-III™ Anterior Cervical Plate SystemNexus Spine, LLC2023-02-02590
K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC2022-03-182210
K181621Stable-C Interbody SystemNexus Spine, LLC2018-10-191210
K181702Tranquil-L Interbody SystemNexus Spine, LLC2018-09-21860
K181483Tranquil Interbody SystemNexus Spine, LLC2018-08-27830
K170297Tranquil Interbody SystemNexus Spine, LLC2017-06-271470
K160820PressON Pro Spinal Fixation SystemNexus Spine, LLC2016-06-28960
K133287PRESSON SPINAL FIXATION SYSTEMNexus Spine, LLC2014-02-251230

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