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