The following data is part of a premarket notification filed by Endotec, Inc. with the FDA for Fanning-pappas Modular Knee Bearing.
| Device ID | K081400 |
| 510k Number | K081400 |
| Device Name: | FANNING-PAPPAS MODULAR KNEE BEARING |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | ENDOTEC, INC. 2546 HANSROB RD. Orlando, FL 32804 |
| Contact | Michael Pappas |
| Correspondent | Michael Pappas ENDOTEC, INC. 2546 HANSROB RD. Orlando, FL 32804 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-19 |
| Decision Date | 2009-02-20 |