The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Coonrad/morrey Total Elbow, Model 8105 Series.
| Device ID | K053189 |
| 510k Number | K053189 |
| Device Name: | COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES |
| Classification | Prosthesis, Elbow, Constrained, Cemented |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Laura D Williams |
| Correspondent | Laura D Williams ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | JDC |
| CFR Regulation Number | 888.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-15 |
| Decision Date | 2005-12-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024274105 | K053189 | 000 |
| 00889024274099 | K053189 | 000 |