The following data is part of a premarket notification filed by Cardo Medical Corp. with the FDA for Modificaiton To: Cardo Medical Hip System.
| Device ID | K094045 |
| 510k Number | K094045 |
| Device Name: | MODIFICAITON TO: CARDO MEDICAL HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | CARDO MEDICAL CORP. 10 CLIFTON BLVD SUITE B1 Clifton, NJ 07011 |
| Contact | Dave Lamb |
| Correspondent | Dave Lamb CARDO MEDICAL CORP. 10 CLIFTON BLVD SUITE B1 Clifton, NJ 07011 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-31 |
| Decision Date | 2010-04-22 |
| Summary: | summary |