7D Surgical, Inc.
CA Last updated 22 Oct 2026
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- Devices
- 10
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
7D Surgical System Cranial Application Ref K181041
7D Surgical System Ref K192140
7D Surgical System - Drill Guide Ref K210555
7D Surgical System Ref K183276
7D Surgical System Ref K180352
Envision 3D: Image Guidance System Ref K162375
What 7D Surgical, Inc. makes
7D Surgical, Inc. manufactures surgical systems and related devices including the 7D Surgical System, 7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector, 7D Surgical Flex Array, and various surgical accessories such as the 7D Registration Frame, 7D Flex Iliac Pin Connector, and 7D Pin Guide Block. They also produce specialized applications for cranial procedures, biopsies, and ventricular catheter placement, as well as the Envision 3D Image Guidance System.
The company's products are classified as Class II medical devices and are listed in the FDA 510(k) registry. 7D Surgical, Inc. is based in the United States.
Frequently asked questions
What does 7D Surgical, Inc. manufacture?
7D Surgical, Inc. manufactures surgical systems and related devices including the 7D Surgical System, 7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector, 7D Surgical Flex Array, and various surgical accessories such as the 7D Registration Frame, 7D Flex Iliac Pin Connector, and 7D Pin Guide Block. They also produce specialized applications for cranial procedures, biopsies, and ventricular catheter placement, as well as the Envision 3D Image Guidance System.
Where is 7D Surgical, Inc. based?
7D Surgical, Inc. is based in the United States. The company's location is specified as being in the US, which indicates its country of operation and manufacturing base.
Which regulatory registries list 7D Surgical's devices?
7D Surgical's devices are listed in the FDA 510(k) registry. This registry is for medical devices that are substantially equivalent to existing devices and have been cleared for marketing in the United States.
How are 7D Surgical's devices classified?
7D Surgical's devices are classified as Class II medical devices. Class II devices are those that require general and special controls to ensure their safety and effectiveness, but pose a lower risk to patients than Class III devices.
Information
- Country
- CA