Tritanium® TL Curved Posterior Lumbar Cage

Intervertebral Fusion Device With Bone Graft, Lumbar

Stryker

The following data is part of a premarket notification filed by Stryker with the FDA for Tritanium® Tl Curved Posterior Lumbar Cage.

Pre-market Notification Details

• Device ID: K173476
• 510k Number: K173476
• Device Name: Tritanium® TL Curved Posterior Lumbar Cage
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: Stryker 2 Pearl Court Allendale, NJ 07401
• Contact: Nikin Desai
• Correspondent: Nikin Desai; Stryker 2 Pearl Court Allendale, NJ 07401
• Product Code: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-11-09
• Decision Date: 2018-01-18
• Summary: summary