The following data is part of a premarket notification filed by Excera Orthopedics, Inc. with the FDA for Excera Fitrite Total Hip Arthroplasty System.
| Device ID | K140547 |
| 510k Number | K140547 |
| Device Name: | EXCERA FITRITE TOTAL HIP ARTHROPLASTY SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | EXCERA ORTHOPEDICS, INC. 80 SHELTON TECHNOLOGY CENTER Shelton, CT 06484 |
| Contact | Tim M Lohnes |
| Correspondent | Tim M Lohnes EXCERA ORTHOPEDICS, INC. 80 SHELTON TECHNOLOGY CENTER Shelton, CT 06484 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-04 |
| Decision Date | 2015-01-22 |
| Summary: | summary |