CTL Medical Corporation
FDA Regulatory Profile
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 14
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2501-2020 | Class II | CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H7mm, Part #018.1307. | August 21, 2019 |
| Z-2503-2020 | Class II | CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308. | August 21, 2019 |
| Z-2504-2020 | Class II | CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H8mm, Part #018.1908. | August 21, 2019 |
| Z-2502-2020 | Class II | CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H7mm, Part #018.1907. | August 21, 2019 |
| Z-1030-2019 | Class II | CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050 | July 5, 2018 |
| Z-1031-2019 | Class II | CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050 | July 5, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K233947 | KLIMT Expandable Lumbar Interbody Fusion (LIF) Cage System | October 10, 2024 |
| K231715 | MONDRIAN Anterior Lumbar Plate System | January 26, 2024 |
| K231359 | RODIN Expandable Lumbar Cage System | June 9, 2023 |
| K220513 | NITRO Interbody Fusion Cage System Family | April 25, 2023 |
| K220334 | MONET Anterior Cervical Plate System | November 9, 2022 |
| K211785 | CASSATT SIJ Fixation System | October 17, 2022 |
| K213641 | MONDRIAN ALIF Cage with Supplementary Fixation Plate | September 15, 2022 |
| K213491 | Universal Pilot Guidance Instrument System | May 12, 2022 |
| K192863 | MONDRIAN Lumbar Interbody Fusion Cage System | August 26, 2020 |
| K182151 | MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate | October 11, 2018 |
| K172788 | MONET Anterior Cervical Interbody Fusion Cage System | June 25, 2018 |
| K173185 | SEURAT Universal Pedicle Screw System | February 14, 2018 |
| K172212 | MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK | January 9, 2018 |
| K162682 | MATISSE Anterior Cervical Interbody Fusion Cage System | June 1, 2017 |