Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)

FDA 510(k) K180818 · Tenon Medical, Inc.

Substantially Equivalent

510(k) numberK180818

Submission

Device name
Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)
Applicant
Tenon Medical, Inc.
San Ramon, CA, US
Received
March 29, 2018
Decision date
June 13, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OUR – Sacroiliac Joint Fixation
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3040
Specialty
Orthopedic
Implant
Yes

sacroiliac joint fusion

Other 510(k)s with product code OUR

510(k)DeviceApplicantDecision
K261381TiLink-L™ SI Joint Fusion SystemOUR · Traditional SurGenTec, LLC08/24/2026SE
K260477CATAMARAN™ SI Joint Fusion SystemOUR · Traditional Tenon Medical04/08/2026SE
K253488iFuse INTRA Ti™ Implant SystemOUR · Traditional SI-BONE, Inc.02/11/2026SE
K253611Falco Fusion SystemOUR · Traditional Mcnicoll Surgical, Inc.01/29/2026SE
K252834Sacroiliac Joint Truss System (SJTS)OUR · Traditional 4Web Medical01/28/2026SE
K251365OptumSI Implant SystemOUR · Traditional Si Solutions, LLC11/20/2025SE
K252322SIros-X SystemOUR · Traditional Genesys Spine10/22/2025SE
K253094iFuse Bedrock Granite Implant SystemOUR · Special SI-BONE, Inc.10/09/2025SE
K250894Eminent Spine Posterior SI SystemOUR · Traditional Eminent Spine10/07/2025SE
K250647SImmetry+ SystemOUR · Traditional Sivantage07/29/2025SE

More from Sivantage

510(k)DeviceDecision
K260477CATAMARAN™ SI Joint Fusion SystemOUR · Traditional 04/08/2026SE
K250403Catamaran SI Joint Fusion SystemOUR · Special 03/21/2025SE
K231944CATAMARAN SI Joint Fusion SystemOUR · Traditional 08/24/2023SE

Questions and answers

When was Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) cleared by the FDA?

Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) (K180818) received a 510(k) decision of Substantially Equivalent on June 13, 2018, 76 days after the submission was received.

What is the product code of K180818?

The FDA product code is OUR – Sacroiliac Joint Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3040.