Tritanium® PL 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® Pl Cage.

Pre-market Notification Details

• Device ID: K160955
• 510k Number: K160955
• Device Name: Tritanium® PL Cage
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: STRYKER 2 Pearl Court Allendale, NJ 07401
• Contact: Deirdre Jayko
• Correspondent: Deirdre Jayko; 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: 2016-04-05
• Decision Date: 2016-07-21
• Summary: summary