The following data is part of a premarket notification filed by Zimmer, Inc with the FDA for Zimmer M/l Taper Hip Prosthesis With Kinectiv Technology Mr Labeling.
| Device ID | K182678 |
| 510k Number | K182678 |
| Device Name: | Zimmer M/L Taper Hip Prosthesis With Kinectiv Technology MR Labeling |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | Zimmer, Inc PO Box 708 Warsaw, IN 46581 -0708 |
| Contact | Caleb Barylski |
| Correspondent | Caleb Barylski Zimmer, Inc PO Box 708 Warsaw, IN 46581 -0708 |
| Product Code | LPH |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | LZO |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-26 |
| Decision Date | 2019-05-31 |
| Summary: | summary |