The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Nexgen Complete Knee Solution Rotatng Hinge Knee.
| Device ID | K013385 |
| 510k Number | K013385 |
| Device Name: | NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE |
| Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Stephen Mckelvey |
| Correspondent | Stephen Mckelvey ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | KRO |
| CFR Regulation Number | 888.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-12 |
| Decision Date | 2002-01-09 |
| Summary: | summary |