Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Providence Medical Technology, Inc. · Predicate Candidate Screening

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

85 daysmedian FDA review time
253 days90th percentile
21clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.2026-06-18290
K253676CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCProvidence Medical Technology, Inc.2026-05-141740
K253190CORUS-LX ImplantProvidence Medical Technology, Inc.2025-11-20550
K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.2025-07-301170
K251885CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX ImplantProvidence Medical Technology, Inc.2025-07-10200
K241035PMT Posterior Cervical Stabilization System (PCSS)Providence Medical Technology, Inc.2024-06-25700
K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.2024-05-03580
K230840PMT Facet Fixation System, Lumbar (PMT FFS-LX)Providence Medical Technology, Inc.2023-12-192670
K230297PMT Expandable Cage (PMT EXP)Providence Medical Technology, Inc.2023-08-111900
K220951PMT Facet Fixation System (PMT FFS)Providence Medical Technology, Inc.2022-12-092520
K212636CORUS Spinal System-XProvidence Medical Technology, Inc.2021-10-15570
K183589PMT Facet ScrewProvidence Medical Technology, Inc.2019-10-112940
K190201CORUS Spinal SystemProvidence Medical Technology, Inc.2019-03-08320
K180876DTRAX Spinal SystemProvidence Medical Technology, Inc.2018-05-18450
K172279PMT Posterior Fixation SystemProvidence Medical Technology, Inc.2017-09-20540
K170698ALLY(TM) Bone ScrewsProvidence Medical Technology, Inc.2017-05-31850
K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc.2017-03-10880
K163374ALLY™ Facet ScrewsProvidence Medical Technology, Inc.2017-02-16770
K161642CAVUX™ Cervical CageProvidence Medical Technology, Inc.2016-10-071150
K122801PROVIDENCE CERVICAL CAGEProvidence Medical Technology, Inc.2013-05-242530
K121713PMT BONE SCREWSProvidence Medical Technology, Inc.2012-09-271080

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