Manufacturer
7D Surgical7D Surgical System - Percutaneous Application (7D Flash Frame)
Country / Region:Canada (CA)Submission type:Special
Product code OLO· 21 CFR 882.4560
Product code
OLO
21 CFR 882.4560
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K220522
- Device name
- 7D Surgical System - Percutaneous Application (7D Flash Frame)
- Company
- 7D Surgical
- Country / Region
- Canada(CA)
- Product code
- OLO
- Device class
- Class 2
- Regulation number
- 21 CFR 882.4560
- Date received
- 2022-02-23
- Decision date
- 2022-05-20
- Submission type
- Special
- Technology type
- Image Guided Surgery(AI inferred)
- Clinical applications
- Spine SurgeryNavigation System
- Primary application
- Spine Surgery
- Classification source
- AI classified
Indications for Use
The 7D Surgical System Percutaneous Application is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons. The system is also intended to be used as the primary surgical luminaire during image guided surgery. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure can be identified.
Intended Use
The 7D Surgical System Percutaneous Application is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons. The system is also intended to be used as the primary surgical luminaire during image guided surgery. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure can be identified.
Device Description
Common/usual name: Computer-assisted surgical device. Proprietary name: 7D Surgical System - Percutaneous Application (7D Flash Frame). These devices are classified as follows: Classification Name: Stereotaxic instrument, 21 CFR §882.4560, Product Code: OLO.
Summary parsed at:2026-06-24 04:32:29 UTC
Predicate devices
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Cited as predicate
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