K&J Consulting Corp.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under 3 spellings of the applicant name “K&J Consulting Corp.” (first 2021, latest 2025), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 60 days. Since 2017 the median was 60 days, against 81 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 |
|---|---|---|
| 2021 | 1 | 58 |
| 2022 | 0 | — |
| 2023 | 4 | 60 |
| 2024 | 0 | — |
| 2025 | 1 | 205 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name K&J Consulting Corp. took a median 60 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 81 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 | 2 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| MRW | System, Facet Screw Spinal Device | 1 | 1 |
| NKB | Thoracolumbosacral Pedicle Screw System | 1 | 1 |
| NKG | Posterior Cervical Screw System | 1 | 1 |
Review panels
- Orthopedic (6)
Most recent K&J Consulting Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250335 | IVA & AEON Cervical and Lumbar Cage System | ODP | 2025-08-29 | 205 |
| K232877 | FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C Stand Alone System | MRW | 2023-12-13 | 89 |
| K233332 | Statera-C Spinal System | NKG | 2023-11-27 | 59 |
| K232586 | Rexious Spinal Fixation System, Statera Spinal System, Statera-M Spinal System | NKB | 2023-10-24 | 60 |
| K231460 | FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM & BALTEUM-ONE Lumbar Plate System, and Osprey Anterior Cervical Plate System | KWQ | 2023-07-16 | 58 |
| K212038 | K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage | ODP | 2021-08-27 | 58 |
Recalls
openFDA lists no recalls under a recalling firm named K&J Consulting 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.
FDA spellings included
FDA records this applicant under 3 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- K&J Consulting Corp. (3)
- K&J Consulting Corporation (2)
- K&J Consulting (1)
Frequently asked questions
How many FDA 510(k) clearances are listed under K&J Consulting Corp.?
FDA lists 6 510(k) clearances under 3 spellings of the applicant name “K&J Consulting Corp.” (first 2021, latest 2025), across 5 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 K&J Consulting Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name K&J Consulting Corp. is 60 days. Since 2017: 60 days, versus 81 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under K&J Consulting Corp.?
The most frequent FDA product codes under this applicant name are ODP (Intervertebral Fusion Device With Bone Graft, Cervical, 2); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 1); MRW (System, Facet Screw Spinal Device, 1).
Next steps
- See all 6 K&J Consulting Corp. clearances with predicates and recalls
- Run predicate analysis for product code ODP, K&J Consulting 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 (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.