The following data is part of a premarket notification filed by Medtronic Advanced Energy with the FDA for Medtronic Total Hip Arthroplasty System.
| Device ID | K183129 |
| 510k Number | K183129 |
| Device Name: | Medtronic Total Hip Arthroplasty System |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | Medtronic Advanced Energy 180 International Drive Portsmouth, NH 03801 |
| Contact | Gina Cunsolo |
| Correspondent | Gina Cunsolo Medtronic Advanced Energy 180 International Drive Portsmouth, NH 03801 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-13 |
| Decision Date | 2019-07-26 |
| Summary: | summary |