Sofamor Co.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Sofamor Co.” (first 1985, latest 1996), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 214 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 |
|---|---|---|---|
| KWP | Appliance, Fixation, Spinal Interlaminal | 3 | 3 |
| JDN | Implant, Fixation Device, Spinal | 1 | 1 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
Review panels
- Orthopedic (5)
Most recent Sofamor Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K940744 | SOFAMOR, LAURAIN DEWALD ANTERIOR FIXATION | KWQ | 1996-01-30 | 712 |
| K945022 | APOFIX CERVICAL SPINE FIXATION | KWP | 1995-05-15 | 214 |
| K934007 | SOFAMOR ORFIL SPINE FIXATION SYSTEM | KWP | 1994-06-02 | 288 |
| K873977 | NEW C-D SYSTEM FOR SPINAL SURGERY | JDN | 1987-12-07 | 69 |
| K843687 | ROD FOR RACHIS SURGERY | KWP | 1985-01-10 | 114 |
Recalls
openFDA lists no recalls under a recalling firm named Sofamor Co..
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 Danek (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sofamor Co.?
FDA lists 5 510(k) clearances under the applicant name “Sofamor Co.” (first 1985, latest 1996), across 3 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 Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sofamor Co. is 214 days.
Which FDA product codes appear under Sofamor Co.?
The most frequent FDA product codes under this applicant name are KWP (Appliance, Fixation, Spinal Interlaminal, 3); JDN (Implant, Fixation Device, Spinal, 1); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 1).
Next steps
- See all 5 Sofamor Co. clearances with predicates and recalls
- Run predicate analysis for product code KWP, Sofamor Co.'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.