Atlas FDA

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

Xenco Medical, LLC · Predicate Candidate Screening

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

98 daysmedian FDA review time
259 days90th percentile
16clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC2025-01-29630
K223059Xenco Medical InterAlign Cervical Interbody SystemXenco Medical, LLC2023-06-072500
K213456Xenco Medical Multilevel CerviKitXenco Medical, LLC2021-12-21560
K191074Sorrento Bone Graft SubstituteXenco Medical, LLC2019-09-271570
K190364CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC2019-04-18620
K173933Sorrento Bioglass Bone Graft SubstituteXenco Medical, LLC2018-09-132610
K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC2018-08-241930
K170611SETx Pedicle Screw SystemXenco Medical, LLC2017-05-25850
K160313Xenco Medical Cervical Interbody SystemXenco Medical, LLC2016-10-212590
K161478Xenco Medical Posterior Cervical SystemXenco Medical, LLC2016-09-06980
K160986Xenco Medical Pedicle Screw SystemXenco Medical, LLC2016-05-04260
K152987Xenco Medical Cervical Interbody System, Xenco Medical LumbaXenco Medical, LLC2015-12-11590
K152302Xenco Medical Cervical Interbody System (Argus)Xenco Medical, LLC2015-09-10270
K151733Xenco Medical Pedicle Screw SystemXenco Medical, LLC2015-09-04700
K143158Xenco Medical Lumbar Interbody SystemXenco Medical, LLC2015-03-201370
K140786XENCO MEDICAL CERVICAL INTERBODY SYSTEMXenco Medical, LLC2014-09-031560

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