510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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SCYClass II

Sacroiliac Joint Guidewire Placement Device

21 CFR 888.3040 / Orthopedic
FDA source (opens on fda.gov)

SCY is the FDA product code for Sacroiliac Joint Guidewire Placement Device, a class II device type, regulated under 21 CFR 888.3040. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
SCY
Device name
Sacroiliac Joint Guidewire Placement Device
FDA 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.
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code SCY

By decision year
1 clearance under product code SCY with a decision year between 2024 and 2024, 2024 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SCY by decision year
YearClearances
20241

Applicants with the most clearances

Product code SCY
Applicants holding the most 510(k) clearances under product code SCY
ApplicantClearances
Spineguard, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code