Corelink, LLC: FDA filings under this applicant name
FDA lists 35 510(k) clearances under the applicant name “Corelink, LLC” (first 2008, latest 2023), across 13 product codes in 1 review panel. Median 510(k) review time under this name: 120 days. Since 2017 the median was 112 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 |
|---|---|---|
| 2012 | 5 | 153 |
| 2013 | 3 | 105 |
| 2014 | 1 | 74 |
| 2015 | 1 | 135 |
| 2016 | 1 | 178 |
| 2017 | 2 | 232 |
| 2018 | 3 | 134 |
| 2019 | 2 | 300 |
| 2020 | 3 | 103 |
| 2021 | 2 | 45 |
| 2022 | 4 | 54 |
| 2023 | 6 | 110 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Corelink, LLC took a median 112 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 |
|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | 7 | 7 |
| NKB | Thoracolumbosacral Pedicle Screw System | 6 | 6 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 5 | 5 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 4 | 4 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 3 | 3 |
| OUR | Sacroiliac Joint Fixation | 2 | 2 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 2 | 2 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 | 1 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 1 | 1 |
| MNI | Orthosis, Spinal Pedicle Fixation | 1 | 1 |
Plus 3 more product codes.
Review panels
- Orthopedic (35)
Most recent Corelink, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231743 | F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System | MAX | 2023-12-08 | 177 |
| K231494 | CoreLink Robotic Navigation Instruments | OLO | 2023-10-27 | 157 |
| K232116 | CoreLink Navigation Instruments | OLO | 2023-08-16 | 30 |
| K230329 | F3D Interbody System | ODP | 2023-06-06 | 120 |
| K230880 | CoreLink Navigation Instruments | OLO | 2023-05-02 | 33 |
| K223708 | Entasis 3D Dual-Lead Sacroiliac Implant System | OUR | 2023-03-21 | 99 |
| K221776 | NextGen Pedicle Screw System | NKB | 2022-08-09 | 49 |
| K220973 | CoreLink Navigation Instruments | OLO | 2022-06-01 | 58 |
| K211417 | F3D-C2 Cervical Stand-Alone System | OVE | 2022-02-04 | 273 |
| K214059 | CoreLink Navigation Instruments | OLO | 2022-01-19 | 23 |
25 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2022-10-20.
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 Corelink, LLC?
FDA lists 35 510(k) clearances under the applicant name “Corelink, LLC” (first 2008, latest 2023), across 13 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 Corelink, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Corelink, LLC is 120 days. Since 2017: 112 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Corelink, LLC?
The most frequent FDA product codes under this applicant name are OLO (Orthopedic Stereotaxic Instrument, 7); NKB (Thoracolumbosacral Pedicle Screw System, 6); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 5).
Next steps
- See all 35 Corelink, LLC clearances with predicates and recalls
- Run predicate analysis for product code OLO, Corelink, 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.