The following data is part of a premarket notification filed by The Progressive Orthopaedic Company, Llc with the FDA for Progressive Orthopaedic Total Hip System.
Device ID | K143314 |
510k Number | K143314 |
Device Name: | Progressive Orthopaedic Total Hip System |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
Applicant | The Progressive Orthopaedic Company, LLC 801 US Highway 1, Suite B North Palm Beach, FL 33408 |
Contact | Scott Keiser |
Correspondent | Thomas Smith The Progressive Orthopaedic Company, LLC 801 US Highway 1, Suite B North Palm Beach, FL 33408 |
Product Code | LPH |
CFR Regulation Number | 888.3358 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-11-19 |
Decision Date | 2015-02-27 |
Summary: | summary |