Ctl Medical Corporation: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Ctl Medical Corporation” (first 2017, latest 2024), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 263 days. Since 2017 the median was 263 days, against 90 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 1 | 248 |
| 2018 | 4 | 154 |
| 2019 | 0 | — |
| 2020 | 1 | 324 |
| 2021 | 0 | — |
| 2022 | 4 | 290 |
| 2023 | 2 | 228 |
| 2024 | 2 | 264 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ctl Medical Corporation took a median 263 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 4 | 4 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 4 | 4 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 | 2 |
| NKB | Thoracolumbosacral Pedicle Screw System | 1 | 1 |
| OLO | Orthopedic Stereotaxic Instrument | 1 | 1 |
| OUR | Sacroiliac Joint Fixation | 1 | 1 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 1 | 1 |
Review panels
- Orthopedic (14)
Most recent Ctl Medical Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233947 | KLIMT Expandable Lumbar Interbody Fusion (LIF) Cage System | MAX | 2024-10-10 | 301 |
| K231715 | MONDRIAN Anterior Lumbar Plate System | KWQ | 2024-01-26 | 227 |
| K231359 | RODIN Expandable Lumbar Cage System | MAX | 2023-06-09 | 30 |
| K220513 | NITRO Interbody Fusion Cage System Family | ODP | 2023-04-25 | 427 |
| K220334 | MONET Anterior Cervical Plate System | KWQ | 2022-11-09 | 278 |
| K211785 | CASSATT SIJ Fixation System | OUR | 2022-10-17 | 495 |
| K213641 | MONDRIAN ALIF Cage with Supplementary Fixation Plate | MAX | 2022-09-15 | 301 |
| K213491 | Universal Pilot Guidance Instrument System | OLO | 2022-05-12 | 192 |
| K192863 | MONDRIAN Lumbar Interbody Fusion Cage System | MAX | 2020-08-26 | 324 |
| K182151 | MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate | OVE | 2018-10-11 | 64 |
4 earlier clearances. See the full list in Caduvo.
Recalls
6 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2019-08-21.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ctl Medical Corporation?
FDA lists 14 510(k) clearances under the applicant name “Ctl Medical Corporation” (first 2017, latest 2024), across 7 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ctl Medical Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ctl Medical Corporation is 263 days. Since 2017: 263 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ctl Medical Corporation?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 4); ODP (Intervertebral Fusion Device With Bone Graft, Cervical, 4); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 2).
Next steps
- See all 14 Ctl Medical Corporation clearances with predicates and recalls
- Run predicate analysis for product code MAX, Ctl Medical Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.