The following data is part of a premarket notification filed by Cardo Medical, Inc with the FDA for Cardo Medical Femoral Cement Restrictor, Model 503-mcrx.
| Device ID | K101032 |
| 510k Number | K101032 |
| Device Name: | CARDO MEDICAL FEMORAL CEMENT RESTRICTOR, MODEL 503-MCRX |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | CARDO MEDICAL, INC 10 CLIFTON BLVD SUITE B1 Clifton, NJ 07011 |
| Contact | Michael Kvitnitsky |
| Correspondent | Michael Kvitnitsky CARDO MEDICAL, INC 10 CLIFTON BLVD SUITE B1 Clifton, NJ 07011 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-14 |
| Decision Date | 2010-07-08 |
| Summary: | summary |