The following data is part of a premarket notification filed by Cardo Medical Corp. with the FDA for Cardo Medical Anterior Cervical Plate System.
| Device ID | K091396 |
| 510k Number | K091396 |
| Device Name: | CARDO MEDICAL ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | CARDO MEDICAL CORP. 1033 US HIGHWAY 46E Clifton, NJ 07013 |
| Contact | Denise Duchene |
| Correspondent | Denise Duchene CARDO MEDICAL CORP. 1033 US HIGHWAY 46E Clifton, NJ 07013 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-10 |
| Decision Date | 2009-08-05 |
| Summary: | summary |