Kalitec Direct, LLC: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Kalitec Direct, LLC” (first 2011, latest 2018), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 95 days. Since 2017 the median was 94 days, against 88 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 177 |
| 2014 | 2 | 107 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 4 | 84 |
| 2018 | 1 | 120 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Kalitec Direct, LLC took a median 94 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 88 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 | 2 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 2 | 2 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 | 2 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 | 1 |
| NKB | Thoracolumbosacral Pedicle Screw System | 1 | 1 |
| PEK | Spinous Process Plate | 1 | 1 |
Review panels
- Orthopedic (9)
Most recent Kalitec Direct, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K180401 | TiWAVE-C Porous Titanium Cervical Cage | ODP | 2018-06-14 | 120 |
| K172808 | CosmoLock Pedicle Screw System | NKB | 2017-10-25 | 37 |
| K172086 | Matira Anterior Cervical System | KWQ | 2017-09-22 | 73 |
| K170342 | Ocata Anterior Cervical System | KWQ | 2017-05-09 | 95 |
| K163471 | Kalitec Direct InSePtion MIS Fixation System | PEK | 2017-03-16 | 94 |
| K140678 | COSMOLOCK PEDICLE SCREW SYSTEM | MNH | 2014-06-19 | 93 |
| K133815 | INTESS CERVICAL CAGE SYSTEM | ODP | 2014-04-16 | 121 |
| K123100 | INTESS LUMBAR CAGE | MAX | 2013-03-28 | 177 |
| K111370 | ODALYS PEDICLE SCREW SYSTEM | MNH | 2011-09-21 | 128 |
Recalls
openFDA lists no recalls under a recalling firm named Kalitec Direct, LLC.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Kalitec Medical, LLC (2 510(k)s)
- Kalitec Direct, LLC Doing Business AS Kalitec Medical (1 510(k)s)
- Kalitec Medical (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Kalitec Direct, LLC?
FDA lists 9 510(k) clearances under the applicant name “Kalitec Direct, LLC” (first 2011, latest 2018), across 6 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 Kalitec Direct, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kalitec Direct, LLC is 95 days. Since 2017: 94 days, versus 88 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Kalitec Direct, LLC?
The most frequent FDA product codes under this applicant name are KWQ (Appliance, Fixation, Spinal Intervertebral Body, 2); MNH (Orthosis, Spondylolisthesis Spinal Fixation, 2); ODP (Intervertebral Fusion Device With Bone Graft, Cervical, 2).
Next steps
- See all 9 Kalitec Direct, LLC clearances with predicates and recalls
- Run predicate analysis for product code KWQ, Kalitec Direct, LLC'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.