Trident® Tritanium® PST® Acetabular Shells

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

MAKO Surgical Corp.

The following data is part of a premarket notification filed by Mako Surgical Corp. with the FDA for Trident® Tritanium® Pst® Acetabular Shells.

Pre-market Notification Details

• Device ID: K142606
• 510k Number: K142606
• Device Name: Trident® Tritanium® PST® Acetabular Shells
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: MAKO Surgical Corp. 3 Wing Drive Suite 102 Cedar Knolls, NJ 07927
• Contact: Jonathan Reeves
• Correspondent: Jonathan Reeves; M Squared Associates, Inc 2555 Davie Road Ft. Laruderdale, FL 33317
• Product Code: LPH
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-09-15
• Decision Date: 2015-01-26
• Summary: summary