The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Coonrad/morrey Elbow Cement Restrictor.
| Device ID | K040389 |
| 510k Number | K040389 |
| Device Name: | COONRAD/MORREY ELBOW CEMENT RESTRICTOR |
| Classification | Prosthesis, Elbow, Constrained, Cemented |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Noah J Bartsch |
| Correspondent | Noah J Bartsch 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 | 2004-02-17 |
| Decision Date | 2004-05-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024380424 | K040389 | 000 |
| 00889024274082 | K040389 | 000 |