Tritanium® TL Curved Posterior Lumbar Cage

Q: What is the product code of K173476?

The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.

FDA 510(k) K173476 · Stryker

Substantially Equivalent

510(k) numberK173476

Submission

Device name: Tritanium® TL Curved Posterior Lumbar Cage
Applicant: Stryker
Allendale, NJ, US
Received: November 9, 2017
Decision date: January 18, 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: MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3080
Specialty: Orthopedic
Implant: Yes

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

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Questions and answers

When was Tritanium® TL Curved Posterior Lumbar Cage cleared by the FDA?

Tritanium® TL Curved Posterior Lumbar Cage (K173476) received a 510(k) decision of Substantially Equivalent on January 18, 2018, 70 days after the submission was received.

What is the product code of K173476?

The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.