The following data is part of a premarket notification filed by Cardo Medical, Inc with the FDA for Cardo Medical Ceramic Hip System.
| Device ID | K100008 |
| 510k Number | K100008 |
| Device Name: | CARDO MEDICAL CERAMIC HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | CARDO MEDICAL, INC 10 CLIFTON BLVD SUITE B1 Clifton, NJ 07011 |
| Contact | Dave Lamb |
| Correspondent | Dave Lamb CARDO MEDICAL, INC 10 CLIFTON BLVD SUITE B1 Clifton, NJ 07011 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-04 |
| Decision Date | 2010-05-18 |
| Summary: | summary |