Sacroiliac Joint Guidewire Placement Device
A sacroiliac joint guidewire placement device is an orthopedic instrument intended to assist in locating the sacroiliac joint and placing a guidewire within it as part of sacroiliac joint fusion surgery to position implants precisely into the joint. It is classified as FDA Class II (510(k) required) under regulation 888.3040 in the Orthopedic specialty, with product code SCY. The device is not itself an implant and does not support life-sustaining functions.
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Basic Information
- Product Code
- SCY
- Device Class
- FDA class 2
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
Definition
A sacroiliac joint guidewire placement device is intended to be used to assist in locating the sacroiliac joint and placing a guidewire in the joint as part of sacroiliac joint fusion surgeries to place implants into the sacroiliac joint.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K241895 | Cannulated PsiFGuard | Sep 26, 2024 | Substantially Equivalent | Spineguard |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.