Sofamor Danek: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Sofamor Danek” (first 1999, latest 1999), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 22 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Medtronic, based on public ownership records.
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 |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 | 0 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 1 | 1 |
Review panels
- Orthopedic (2)
Most recent Sofamor Danek 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K991460 | MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM | MNH | 1999-05-19 | 22 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P970015 | PMA | INTER FIX THREADED FUSION DEVICE | 1999-05-14 |
Recalls
openFDA lists no recalls under a recalling firm named Sofamor Danek.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Sofamor Danek USA,Inc. (42 510(k)s)
- Sofamor Danek Mfg., Inc. (23 510(k)s)
- Sofamor Co. (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sofamor Danek?
FDA lists 1 510(k) clearance under the applicant name “Sofamor Danek” (first 1999, latest 1999), plus 1 PMA decision, across 2 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 Sofamor Danek?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sofamor Danek is 22 days.
Which FDA product codes appear under Sofamor Danek?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 1); MNH (Orthosis, Spondylolisthesis Spinal Fixation, 1).
Next steps
- See all 1 Sofamor Danek clearances with predicates and recalls
- Run predicate analysis for product code MAX, Sofamor Danek'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.