7D Surgical, Inc.
Toronto, CA
7D Surgical, Inc. appears in FDA device records in Toronto, CA. FDA records list 10 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 10
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 10 510(k) clearances for 7D Surgical, Inc. between 2016 and 2022. The busiest year on record is 2019, with 3. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 1 |
| 2018 | 2 |
| 2019 | 3 |
| 2020 | 1 |
| 2021 | 2 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K220522 | 7D Surgical System - Percutaneous Application (7D Flash Frame) | OLO | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| K210555 | 7D Surgical System - Drill Guide | OLO | Substantially Equivalent | |
| K201966 | 7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array | OLO | Substantially Equivalent | |
| K192945 | 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application | HAW | Substantially Equivalent | |
| K192140 | 7D Surgical System | OLO | Substantially Equivalent | |
| K183276 | 7D Surgical System | HAW | Substantially Equivalent | |
| K181041 | 7D Surgical System Cranial Application | HAW | Substantially Equivalent | |
| K180352 | 7D Surgical System | OLO | Substantially Equivalent | |
| K162375 | Envision 3D: Image Guidance System | OLO | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain