510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K183119Substantially Equivalent

SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments

Globus Medical, Inc., Audubon PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K183119 is the FDA 510(k) clearance record for SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments, a class II device, cleared for Globus Medical, Inc. on under FDA product code OUR (Sacroiliac Joint Fixation). FDA's definition for product code OUR reads: "sacroiliac joint fusion". FDA records list 217 510(k) clearances for Globus Medical, Inc., from to . As of , FDA records show no recalls naming K183119.

Clearance record

Decision date
Received
(89 days to decision)
Product code
OUR Sacroiliac Joint Fixation
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Globus Medical, Inc. Valley Forge Business Center, Audubon PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OUR

Trailing 12 months
6 clearances under product code OUR in the twelve months to October 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code OUR, trailing twelve months
MonthClearances
November 20251
December 20250
January 20262
February 20261
March 20260
April 20261
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260