Safe Orthopaedics: FDA clearances and approvals
Safe Orthopaedics has 13 FDA 510(k) clearances (first 2011, latest 2020), across 3 product codes in 1 review panel. Median 510(k) review time: 72 days. openFDA lists 1 product recall by a recalling firm named Safe Orthopaedics.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 82 |
| 2013 | 1 | 56 |
| 2014 | 2 | 74 |
| 2015 | 4 | 70 |
| 2016 | 1 | 111 |
| 2017 | 1 | 15 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 42 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Safe Orthopaedics's cleared 510(k)s took a median 28 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 89 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 9 | 9 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 3 | 3 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 1 | 1 |
Review panels
- Orthopedic (13)
Most recent Safe Orthopaedics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K201648 | Sterispine PS | NKB | 2020-07-30 | 42 |
| K170528 | Sterispine PS | NKB | 2017-03-09 | 15 |
| K162531 | STERISPINE CC | OVE | 2016-12-29 | 111 |
| K151921 | STERISPINE PS | NKB | 2015-10-08 | 87 |
| K151747 | STERISPINE PS | NKB | 2015-10-05 | 98 |
| K151756 | STERISPINE LC CAGE | MAX | 2015-08-21 | 53 |
| K150092 | STERISPINE PS Pedicle Screw | NKB | 2015-02-10 | 25 |
| K140802 | STERISPINE PS | NKB | 2014-06-04 | 65 |
| K133893 | STERISPINE LC CAGE | MAX | 2014-03-14 | 84 |
| K130632 | STERISPINE PS PEDICLE SCREW | NKB | 2013-05-03 | 56 |
3 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: 2022-06-03.
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 Safe Orthopaedics have?
Safe Orthopaedics has 13 FDA 510(k) clearances (first 2011, latest 2020), across 3 product codes in 1 review panel.
How long does FDA take to clear Safe Orthopaedics's 510(k)s?
The median time from FDA receipt to decision across Safe Orthopaedics's cleared 510(k)s is 72 days.
What devices does Safe Orthopaedics make?
Its most frequent FDA product codes are NKB (Thoracolumbosacral Pedicle Screw System, 9); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 3); OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical, 1).
Has Safe Orthopaedics had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Safe Orthopaedics; the most recent began 2022-06-03. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 13 Safe Orthopaedics clearances with predicates and recalls
- Run predicate analysis for product code NKB, Safe Orthopaedics'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.