The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Segmental System.
| Device ID | K192798 |
| 510k Number | K192798 |
| Device Name: | Zimmer Segmental System |
| Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Applicant | Zimmer, Inc. 1800 W. Center Street Warsaw, IN 46580 |
| Contact | Yoriko Kobayashi |
| Correspondent | Yoriko Kobayashi Zimmer, Inc. 1800 W. Center Street Warsaw, IN 46580 |
| Product Code | KRO |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWL |
| Subsequent Product Code | KWY |
| Subsequent Product Code | KWZ |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-30 |
| Decision Date | 2020-12-10 |