Atlas FDA

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

Ctl Medical Corporation · Predicate Candidate Screening

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

278 daysmedian FDA review time
427 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation2024-10-103010
K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation2024-01-262270
K231359RODIN™ Expandable Lumbar Cage SystemCtl Medical Corporation2023-06-09300
K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation2023-04-254270
K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation2022-11-092780
K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation2022-10-174950
K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation2022-09-153010
K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation2022-05-121920
K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation2020-08-263240
K182151MONET Anterior Cervical Interbody Fusion Cage System with SuCtl Medical Corporation2018-10-11640
K172788MONET™ Anterior Cervical Interbody Fusion Cage SystemCtl Medical Corporation2018-06-252830
K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation2018-02-141380
K172212MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PCtl Medical Corporation2018-01-091690
K162682MATISSE Anterior Cervical Interbody Fusion Cage SystemCtl Medical Corporation2017-06-012480

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