The following data is part of a premarket notification filed by Surgtech, Inc., with the FDA for Maluc™ Total Hip Arthroplasty System.
| Device ID | K162125 |
| 510k Number | K162125 |
| Device Name: | MALUC™ Total Hip Arthroplasty System |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | SurgTech, Inc., 24600 Center Ridge Road, Suite 195 Westlake, OH 44145 |
| Contact | Xuegong Yu |
| Correspondent | Kellen Hills Orchid Design 4600 E Shelby Dr Memphis, TN 38118 |
| Product Code | JDI |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-01 |
| Decision Date | 2017-05-10 |
| Summary: | summary |