The following data is part of a premarket notification filed by Zimmer Inc with the FDA for Zimmer Nexel Total Elbow, Connrad/morrey Total Elbow.
| Device ID | K181307 |
| 510k Number | K181307 |
| Device Name: | Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow |
| Classification | Prosthesis, Elbow, Constrained, Cemented |
| Applicant | Zimmer Inc P.O. Box 708 Warsaw, IN 46581 -0708 |
| Contact | Patricia Sandborn Beres |
| Correspondent | Patricia Sandborn Beres Zimmer Inc P.O. Box 708 Warsaw, IN 46581 -0708 |
| Product Code | JDC |
| CFR Regulation Number | 888.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-17 |
| Decision Date | 2019-01-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024274228 | K181307 | 000 |
| 00889024274211 | K181307 | 000 |
| 00889024639805 | K181307 | 000 |
| 00889024639799 | K181307 | 000 |