The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Nexel Total Elbow Ulnar Cement Diverter.
| Device ID | K150501 |
| 510k Number | K150501 |
| Device Name: | Zimmer Nexel Total Elbow Ulnar Cement Diverter |
| Classification | Prosthesis, Elbow, Constrained, Cemented |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46580 -0708 |
| Contact | Keith Proctor |
| Correspondent | Caroline Bloemker ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46580 -0708 |
| Product Code | JDC |
| CFR Regulation Number | 888.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-26 |
| Decision Date | 2015-04-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024274327 | K150501 | 000 |
| 00889024466296 | K150501 | 000 |