The following data is part of a premarket notification filed by Responsive Orthopedics, Llc with the FDA for Responsive Orthopedics Total Hip Arthroplasty System.
| Device ID | K163585 |
| 510k Number | K163585 |
| Device Name: | Responsive Orthopedics Total Hip Arthroplasty System |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | Responsive Orthopedics, LLC 5865 E State Road 14 Columbia City, IN 46725 |
| Contact | Kathy Remsen |
| Correspondent | Kathy Remsen Medtronic, Inc. 2600 Sofamor Danek Drive Memphis, TN 38132 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-20 |
| Decision Date | 2017-06-02 |
| Summary: | summary |