The following data is part of a premarket notification filed by Cardo Medical Corp. with the FDA for Cardo Medical Align 360 Medialized Patella Component.
| Device ID | K092803 |
| 510k Number | K092803 |
| Device Name: | CARDO MEDICAL ALIGN 360 MEDIALIZED PATELLA COMPONENT |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | CARDO MEDICAL CORP. 1033 US HIGHWAY 46E SUITE A204 Clifton, NJ 07013 |
| Contact | Denise Duchene |
| Correspondent | Denise Duchene CARDO MEDICAL CORP. 1033 US HIGHWAY 46E SUITE A204 Clifton, NJ 07013 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-11 |
| Decision Date | 2009-12-23 |
| Summary: | summary |