Sonoma Orthopedic Products, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Sonoma Orthopedic Products, Inc.” (first 2008, latest 2017), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 190 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 104 |
| 2016 | 0 | — |
| 2017 | 1 | 283 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Sonoma Orthopedic Products, Inc. took a median 283 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 104 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | 6 | 6 |
| HRS | Plate, Fixation, Bone | 2 | 2 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
Review panels
- Orthopedic (9)
Most recent Sonoma Orthopedic Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K161371 | Sonoma Fifth Metatarsal Repair System | HSB | 2017-02-24 | 283 |
| K142945 | Sonoma Fibula Repair System | HSB | 2015-01-22 | 104 |
| K111550 | SONOMA FASTRAC CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA FASTRAC XXYYY(X=DIA, YYY=LENGTH- IN MM) | HSB | 2011-08-19 | 77 |
| K100112 | SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA, YYY=LENGTH-IN MM) | HSB | 2010-09-28 | 257 |
| K092110 | WAVEON FRACTURE REPAIR SYSTEM (WAVEON RX) | HSB | 2010-01-20 | 190 |
| K090304 | WAVEON WRX BONE FIXATION SYSTEM | HRS | 2009-08-28 | 203 |
| K081832 | ENSPLINTCMX CLAVICLE PIN | HSB | 2008-10-10 | 105 |
| K080778 | ENSPLINT TM BONE SCREW | HWC | 2008-07-10 | 113 |
| K071809 | ENSPLINTRX BONE FIXATION SYSTEM | HRS | 2008-02-21 | 234 |
Recalls
openFDA lists no recalls under a recalling firm named Sonoma Orthopedic Products, Inc..
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.
- Sonoma Pharmaceuticals, Inc. (8 510(k)s)
- Sonoma Orthopedics Products, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sonoma Orthopedic Products, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Sonoma Orthopedic Products, Inc.” (first 2008, latest 2017), 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 Sonoma Orthopedic Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sonoma Orthopedic Products, Inc. is 190 days.
Which FDA product codes appear under Sonoma Orthopedic Products, Inc.?
The most frequent FDA product codes under this applicant name are HSB (Rod, Fixation, Intramedullary And Accessories, 6); HRS (Plate, Fixation, Bone, 2); HWC (Screw, Fixation, Bone, 1).
Next steps
- See all 9 Sonoma Orthopedic Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HSB, Sonoma Orthopedic Products, Inc.'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.