Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list CTL Medical Corporation with 14 510(k) clearances and 6 device recalls. The most recent is a 510(k) clearance dated Oct 10, 2024: KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 10, 2024 | KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemK233947 · MAX | 510(k) clearances |
| Jan 26, 2024 | MONDRIAN™ Anterior Lumbar Plate SystemK231715 · KWQ | 510(k) clearances |
| Jun 9, 2023 | RODIN™ Expandable Lumbar Cage SystemK231359 · MAX | 510(k) clearances |
| Apr 25, 2023 | NITRO Interbody Fusion Cage System FamilyK220513 · ODP | 510(k) clearances |
| Nov 9, 2022 | MONET Anterior Cervical Plate SystemK220334 · KWQ | 510(k) clearances |
| Oct 17, 2022 | CASSATT™ SIJ Fixation SystemK211785 · OUR | 510(k) clearances |
| Sep 15, 2022 | MONDRIAN ALIF Cage with Supplementary Fixation PlateK213641 · MAX | 510(k) clearances |
| May 12, 2022 | Universal Pilot Guidance Instrument SystemK213491 · OLO | 510(k) clearances |
| Aug 21, 2019 | CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H7mm, Part #018.1907.Class II · Reports received of the device fracturing during insertion. | Device recalls |
| Aug 21, 2019 | CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H8mm, Part #018.1908.Class II · Reports received of the device fracturing during insertion. | Device recalls |
| Aug 21, 2019 | CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308.Class II · Reports received of the device fracturing during insertion. | Device recalls |
| Aug 21, 2019 | CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H7mm, Part #018.1307.Class II · Reports received of the device fracturing during insertion. | Device recalls |
| Jul 5, 2018 | CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050Class II · the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during surgery, the anti-toggl | Device recalls |
| Jul 5, 2018 | CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050Class II · the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during surgery, the anti-toggl | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built