Sofamor Danek Mfg., Inc.: FDA clearances and approvals
Sofamor Danek Mfg., Inc. has 23 FDA 510(k) clearances (first 1992, latest 1995), across 7 product codes in 1 review panel. Median 510(k) review time: 268 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 | 10 | 10 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 5 | 5 |
| HRX | Arthroscope | 3 | 3 |
| JDQ | Cerclage, Fixation | 2 | 2 |
| HRS | Plate, Fixation, Bone | 1 | 1 |
| LZN | Cement Obturator | 1 | 1 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 1 | 1 |
Review panels
- Orthopedic (23)
Most recent Sofamor Danek Mfg., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K936294 | SENTRY(TM) ANTERIOR/POSTERIOR SPINAL SYSTEMS | KWP | 1995-12-19 | 739 |
| K930191 | DANEK(TM) SPINAL EPIDURAL ENDOSCOPIC SY | HRX | 1995-09-26 | 985 |
| K932029 | TSRH SPINAL SCREWS | MNH | 1995-01-20 | 633 |
| K922486 | DANEK TISSUE CUTTING AND REMOVAL SYSTEM | HRX | 1993-10-12 | 503 |
| K930807 | SENTRY ANTERIOR SPINAL SYSTEM | KWQ | 1993-10-01 | 227 |
| K930710 | SENTRY POSTERIOR SPINAL SYSTEM | KWP | 1993-10-01 | 232 |
| K923242 | CROSSLINK AXIAL AND OFFSET PLATES | KWQ | 1993-05-19 | 321 |
| K922543 | Z-PLATE ANTERIOR FIXATION SYSTEM | KWQ | 1993-05-19 | 355 |
| K925811 | TSRH CENTRAL POST HOOKS | KWP | 1993-05-18 | 285 |
| K922672 | AUGMENT POSTERIOR SPINAL FIXATION SYSTEM | KWP | 1993-05-18 | 348 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sofamor Danek Mfg., 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 Mfg., Inc. have?
Sofamor Danek Mfg., Inc. has 23 FDA 510(k) clearances (first 1992, latest 1995), across 7 product codes in 1 review panel.
How long does FDA take to clear Sofamor Danek Mfg., Inc.'s 510(k)s?
The median time from FDA receipt to decision across Sofamor Danek Mfg., Inc.'s cleared 510(k)s is 268 days.
What devices does Sofamor Danek Mfg., Inc. make?
Its most frequent FDA product codes are KWP (Appliance, Fixation, Spinal Interlaminal, 10); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 5); HRX (Arthroscope, 3).
Has Sofamor Danek Mfg., Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Sofamor Danek Mfg., Inc. Related entities may recall under other names.
Next steps
- See all 23 Sofamor Danek Mfg., Inc. clearances with predicates and recalls
- Run predicate analysis for product code KWP, Sofamor Danek Mfg., 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.