Reliance Medical Systems, LLC: FDA clearances and approvals
Reliance Medical Systems, LLC has 27 FDA 510(k) clearances (first 2007, latest 2022), across 10 product codes in 1 review panel. Median 510(k) review time: 95 days. Since 2017 its median was 93 days, against 90 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 5 | 90 |
| 2013 | 2 | 106 |
| 2014 | 1 | 31 |
| 2015 | 4 | 222 |
| 2016 | 2 | 110 |
| 2017 | 2 | 56 |
| 2018 | 2 | 78 |
| 2019 | 2 | 181 |
| 2020 | 0 | — |
| 2021 | 1 | 50 |
| 2022 | 1 | 595 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Reliance Medical Systems, LLC's cleared 510(k)s took a median 93 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 |
|---|---|---|---|
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 6 | 6 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 5 | 5 |
| MNI | Orthosis, Spinal Pedicle Fixation | 4 | 4 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 3 | 3 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 3 | 3 |
| MQP | Spinal Vertebral Body Replacement Device | 2 | 2 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 1 | 1 |
| NKB | Thoracolumbosacral Pedicle Screw System | 1 | 1 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 1 | 1 |
| PEK | Spinous Process Plate | 1 | 1 |
Review panels
- Orthopedic (27)
Most recent Reliance Medical Systems, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K202266 | Reliance Cervical IBF System | ODP | 2022-03-29 | 595 |
| K210874 | Reliance Spinal Screw System | NKB | 2021-05-13 | 50 |
| K183049 | Reliance Lumbar IBF System | MAX | 2019-02-15 | 105 |
| K181118 | Reliance Lumbar IBF System | OVD | 2019-01-09 | 257 |
| K180687 | Reliance Lumber IBF System | MAX | 2018-05-15 | 61 |
| K173283 | Reliance Lumbar IBF System | MAX | 2018-01-19 | 95 |
| K173102 | Reliance Cervical IBF System | ODP | 2017-12-29 | 91 |
| K172489 | Reliance Cervical IBF System | ODP | 2017-09-07 | 21 |
| K162066 | Reliance Spinal Screw System | MNH | 2016-12-02 | 129 |
| K160463 | Reliance Lumbar IBF System | MAX | 2016-05-20 | 91 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Reliance Medical Systems, LLC.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Reliance Medical Systems, LLC have?
Reliance Medical Systems, LLC has 27 FDA 510(k) clearances (first 2007, latest 2022), across 10 product codes in 1 review panel.
How long does FDA take to clear Reliance Medical Systems, LLC's 510(k)s?
The median time from FDA receipt to decision across Reliance Medical Systems, LLC's cleared 510(k)s is 95 days. Since 2017: 93 days, versus 90 days for all cleared 510(k)s in the same product codes.
What devices does Reliance Medical Systems, LLC make?
Its most frequent FDA product codes are ODP (Intervertebral Fusion Device With Bone Graft, Cervical, 6); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 5); MNI (Orthosis, Spinal Pedicle Fixation, 4).
Has Reliance Medical Systems, LLC had device recalls?
openFDA lists no recalls under a recalling firm name matching Reliance Medical Systems, LLC. Related entities may recall under other names.
Next steps
- See all 27 Reliance Medical Systems, LLC clearances with predicates and recalls
- Run predicate analysis for product code ODP, Reliance Medical Systems, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.