The following data is part of a premarket notification filed by The Progressive Orthopaedic Company, Llc with the FDA for The Progressive Orthopaedic Total Hip System.
| Device ID | K151424 |
| 510k Number | K151424 |
| Device Name: | The 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 | 2015-05-28 |
| Decision Date | 2016-07-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B035MEBS65201 | K151424 | 000 |
| B035MEBS65151 | K151424 | 000 |
| B035M12000046011 | K151424 | 000 |
| B565M12000046011 | K151424 | 000 |