7D Surgical, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “7D Surgical, Inc.” (first 2016, latest 2022), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 88 days. Since 2017 the median was 86 days, against 103 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2016 | 1 | 127 |
| 2017 | 0 | — |
| 2018 | 2 | 97 |
| 2019 | 3 | 89 |
| 2020 | 1 | 50 |
| 2021 | 2 | 76 |
| 2022 | 1 | 86 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name 7D Surgical, Inc. took a median 86 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 103 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | 7 | 7 |
| HAW | Neurological Stereotaxic Instrument | 3 | 3 |
Review panels
- Orthopedic (7)
- Neurology (3)
Most recent 7D Surgical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220522 | 7D Surgical System - Percutaneous Application (7D Flash Frame) | OLO | 2022-05-20 | 86 |
| K210457 | 7D Registration Frame, 7D Flex Iliac Pin Connector, 7D Pin Guide Block, 7D 3.2 mm Steinmann Pin, 7D Iliac Crest Pin Chuck & Key | OLO | 2021-06-21 | 125 |
| K210555 | 7D Surgical System - Drill Guide | OLO | 2021-03-23 | 26 |
| K201966 | 7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array | OLO | 2020-09-03 | 50 |
| K192945 | 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application | HAW | 2019-11-27 | 40 |
| K192140 | 7D Surgical System | OLO | 2019-11-05 | 89 |
| K183276 | 7D Surgical System | HAW | 2019-08-07 | 257 |
| K181041 | 7D Surgical System Cranial Application | HAW | 2018-08-08 | 111 |
| K180352 | 7D Surgical System | OLO | 2018-05-02 | 83 |
| K162375 | Envision 3D: Image Guidance System | OLO | 2016-12-29 | 127 |
Recalls
openFDA lists no recalls under a recalling firm named 7D Surgical, 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 7D Surgical, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03968965: Evaluation of 3D Machine-vision Image Guided Surgery Spine Navigation (Completed, started 2018-05-09)
Frequently asked questions
How many FDA 510(k) clearances are listed under 7D Surgical, Inc.?
FDA lists 10 510(k) clearances under the applicant name “7D Surgical, Inc.” (first 2016, latest 2022), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by 7D Surgical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name 7D Surgical, Inc. is 88 days. Since 2017: 86 days, versus 103 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under 7D Surgical, Inc.?
The most frequent FDA product codes under this applicant name are OLO (Orthopedic Stereotaxic Instrument, 7); HAW (Neurological Stereotaxic Instrument, 3).
Next steps
- See all 10 7D Surgical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OLO, 7D Surgical, 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.