Zyga Technology, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Zyga Technology, Inc.” (first 2010, latest 2015), across 1 product code in 1 review panel. Median 510(k) review time under this name: 36 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 | 1 | 43 |
| 2014 | 0 | — |
| 2015 | 2 | 124 |
| 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 |
|---|---|---|---|
| OUR | Sacroiliac Joint Fixation | 6 | 6 |
Review panels
- Orthopedic (6)
Most recent Zyga Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K151818 | SImmetry Sacroiliac Joint Fusion System | OUR | 2015-08-05 | 30 |
| K141549 | SImmetry Sacroiliac Joint Fusion System | OUR | 2015-01-15 | 218 |
| K130092 | SIMMETRY SACROILIAC JOINT FUSION SYSTEM | OUR | 2013-02-27 | 43 |
| K111801 | SIMMETRY(TM) SACROILIAC JOINT FUSION SYSTEM | OUR | 2011-07-21 | 24 |
| K110512 | SIMMETRY SACROILIAC JOINT FUSION SYSTEM | OUR | 2011-03-23 | 28 |
| K102907 | SIMMETRY SACROILIAC JOINT FUSION SYSTEM | OUR | 2010-12-14 | 74 |
Recalls
openFDA lists no recalls under a recalling firm named Zyga Technology, 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.
Device clinical trials
An industry sponsor named Zyga Technology, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02425631: CT Follow-Up of the SImmetry Sacroiliac Joint Fusion System (Completed, started 2014-10)
Frequently asked questions
How many FDA 510(k) clearances are listed under Zyga Technology, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Zyga Technology, Inc.” (first 2010, latest 2015), across 1 product code 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 Zyga Technology, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Zyga Technology, Inc. is 36 days.
Which FDA product codes appear under Zyga Technology, Inc.?
The most frequent FDA product codes under this applicant name are OUR (Sacroiliac Joint Fixation, 6).
Next steps
- See all 6 Zyga Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OUR, Zyga Technology, 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.