Cardo Medical Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Cardo Medical Corp.” (first 2009, latest 2010), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 103 days. 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 | 2 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 1 | 1 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 1 | 1 |
Review panels
- Orthopedic (5)
Most recent Cardo Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K101032 | CARDO MEDICAL FEMORAL CEMENT RESTRICTOR, MODEL 503-MCRX | JWH | 2010-07-08 | 85 |
| K100008 | CARDO MEDICAL CERAMIC HIP SYSTEM | LZO | 2010-05-18 | 134 |
| K094045 | MODIFICAITON TO: CARDO MEDICAL HIP SYSTEM | LPH | 2010-04-22 | 112 |
| K092803 | CARDO MEDICAL ALIGN 360 MEDIALIZED PATELLA COMPONENT | JWH | 2009-12-23 | 103 |
| K091396 | CARDO MEDICAL ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 2009-08-05 | 87 |
Recalls
openFDA lists no recalls under a recalling firm named Cardo Medical Corp..
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 Cardo Medical Corp.?
FDA lists 5 510(k) clearances under the applicant name “Cardo Medical Corp.” (first 2009, latest 2010), across 4 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 Cardo Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cardo Medical Corp. is 103 days.
Which FDA product codes appear under Cardo Medical Corp.?
The most frequent FDA product codes under this applicant name are JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 2); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 1); LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, 1).
Next steps
- See all 5 Cardo Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code JWH, Cardo Medical Corp.'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.