Ctl Medical Corporation
Medical device manufacturer in Addison, TX.
14510(k) clearances
0PMA approvals
6recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K233947 | KLIMT Expandable Lumbar Interbody Fusion (LIF) Cage SystemMAX · Traditional | 10/10/2024SE |
| K231715 | MONDRIAN Anterior Lumbar Plate SystemKWQ · Traditional | 01/26/2024SE |
| K231359 | RODIN Expandable Lumbar Cage SystemMAX · Special | 06/09/2023SE |
| K220513 | NITRO Interbody Fusion Cage System FamilyODP · Traditional | 04/25/2023SE |
| K220334 | MONET Anterior Cervical Plate SystemKWQ · Traditional | 11/09/2022SE |
| K211785 | CASSATT SIJ Fixation SystemOUR · Traditional | 10/17/2022SE |
| K213641 | MONDRIAN ALIF Cage with Supplementary Fixation PlateMAX · Traditional | 09/15/2022SE |
| K213491 | Universal Pilot Guidance Instrument SystemOLO · Traditional | 05/12/2022SE |
| K192863 | MONDRIAN Lumbar Interbody Fusion Cage SystemMAX · Traditional | 08/26/2020SE |
| K182151 | MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation PlateOVE · Traditional | 10/11/2018SE |
| K172788 | MONET Anterior Cervical Interbody Fusion Cage SystemODP · Traditional | 06/25/2018SE |
| K173185 | SEURAT Universal Pedicle Screw SystemNKB · Traditional | 02/14/2018SE |
| K172212 | MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEKODP · Traditional | 01/09/2018SE |
| K162682 | MATISSE Anterior Cervical Interbody Fusion Cage SystemODP · Traditional | 06/01/2017SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2504-2020 Class II | CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H8mm, Part #018.1908.Reports received of the device fracturing during insertion. | 08/21/2019Completed |
| Z-2503-2020 Class II | CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308.Reports received of the device fracturing during insertion. | 08/21/2019Completed |
| Z-2502-2020 Class II | CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H7mm, Part #018.1907.Reports received of the device fracturing during insertion. | 08/21/2019Completed |
| Z-2501-2020 Class II | CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H7mm, Part #018.1307.Reports received of the device fracturing during insertion. | 08/21/2019Completed |
| Z-1031-2019 Class II | CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during surgery… | 07/05/2018Terminated |
| Z-1030-2019 Class II | CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during surgery… | 07/05/2018Terminated |