Sofamor Danek USA,Inc.: FDA clearances and approvals
Sofamor Danek USA,Inc. has 42 FDA 510(k) clearances (first 1995, latest 2000), across 9 product codes in 3 review panels. Median 510(k) review time: 134 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KWP | Appliance, Fixation, Spinal Interlaminal | 13 | 13 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 9 | 9 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 7 | 7 |
| MNI | Orthosis, Spinal Pedicle Fixation | 5 | 5 |
| HRX | Arthroscope | 4 | 4 |
| GWG | Endoscope, Neurological | 1 | 1 |
| HRS | Plate, Fixation, Bone | 1 | 1 |
| JEY | Plate, Bone | 1 | 1 |
| MRW | System, Facet Screw Spinal Device | 1 | 1 |
Review panels
- Orthopedic (40)
- Dental (1)
- Neurology (1)
Most recent Sofamor Danek USA,Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K991031 | COLORADO II SPINAL SYSTEM | MNH | 2000-05-10 | 408 |
| K984360 | COLORADO II SPINAL SYSTEM | MNH | 2000-03-30 | 479 |
| K992928 | CD HORIZON SPINAL SYSTEM | MNI | 1999-09-21 | 21 |
| K992110 | PREMIER ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 1999-09-14 | 84 |
| K991036 | DANEK PLATE AND SCREW SYSTEM | MNH | 1999-09-14 | 169 |
| K991198 | DYNA-LOK PLUS SPINAL SYSTEM | KWP | 1999-08-27 | 141 |
| K991364 | MODIFICATION TO TENOR SPINAL SYSTEM-PLATES | MNH | 1999-05-19 | 29 |
| K981676 | CD HORIZON SPINAL SYSTEM | KWP | 1999-01-28 | 261 |
| K980184 | CD SPINAL SYSTEM | MNI | 1998-12-18 | 332 |
| K983672 | DYNA-LOK SPINAL SYSTEM | MNI | 1998-12-16 | 58 |
32 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sofamor Danek USA,Inc..
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 Sofamor Danek USA,Inc. have?
Sofamor Danek USA,Inc. has 42 FDA 510(k) clearances (first 1995, latest 2000), across 9 product codes in 3 review panels.
How long does FDA take to clear Sofamor Danek USA,Inc.'s 510(k)s?
The median time from FDA receipt to decision across Sofamor Danek USA,Inc.'s cleared 510(k)s is 134 days.
What devices does Sofamor Danek USA,Inc. make?
Its most frequent FDA product codes are KWP (Appliance, Fixation, Spinal Interlaminal, 13); MNH (Orthosis, Spondylolisthesis Spinal Fixation, 9); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 7).
Has Sofamor Danek USA,Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Sofamor Danek USA,Inc. Related entities may recall under other names.
Next steps
- See all 42 Sofamor Danek USA,Inc. clearances with predicates and recalls
- Run predicate analysis for product code KWP, Sofamor Danek USA,Inc.'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.