The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer, Inc. Hip Joint Prostheses Mr Labeling I.
| Device ID | K200823 |
| 510k Number | K200823 |
| Device Name: | Zimmer, Inc. Hip Joint Prostheses MR Labeling I |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | Zimmer, Inc. P.O. Box 708 Warsaw, IN 46861 -0708 |
| Contact | Caleb Barylski |
| Correspondent | Caleb Barylski Zimmer, Inc. P.O. Box 708 Warsaw, IN 46861 -0708 |
| Product Code | JDI |
| Subsequent Product Code | KWY |
| Subsequent Product Code | KWZ |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | LZO |
| Subsequent Product Code | OQG |
| Subsequent Product Code | OQH |
| Subsequent Product Code | OQI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-30 |
| Decision Date | 2020-07-09 |