Tritanium® X TL Expandable Curved Posterior Lumbar Cage

Intervertebral Fusion Device With Bone Graft, Lumbar

Stryker Corporation

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

Pre-market Notification Details

• Device ID: K200613
• 510k Number: K200613
• Device Name: Tritanium® X TL Expandable Curved Posterior Lumbar Cage
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: Stryker Corporation 2 Pearl Court Allendale, NJ 07401
• Contact: Jamie Wilson
• Correspondent: Jamie Wilson; Stryker Corporation 2 Pearl Court Allendale, NJ 07401
• Product Code: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-03-09
• Decision Date: 2020-04-15