510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K241895Substantially Equivalent

Cannulated PsiFGuard

Spineguard, Inc., Vincennes, FR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K241895 is the FDA 510(k) clearance record for Cannulated PsiFGuard, a class II device, cleared for Spineguard on under FDA product code SCY (Sacroiliac Joint Guidewire Placement Device). FDA's definition for product code SCY 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". FDA records list 7 510(k) clearances for Spineguard, from to . As of , FDA records show no recalls naming K241895.

Clearance record

Decision date
Received
(90 days to decision)
Product code
SCY Sacroiliac Joint Guidewire Placement Device
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Spineguard 10 Cours Louis Lumiere, 4th Floor, Vincennes, FR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SCY

Trailing 12 months

FDA records hold no clearances under product code SCY in the trailing twelve months.

FDA records show no clearances under product code SCY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SCY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260