The following data is part of a premarket notification filed by Nexxt Medical Inc with the FDA for Blade Anterior Cervical Plate System.
| Device ID | K091936 |
| 510k Number | K091936 |
| Device Name: | BLADE ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | NEXXT MEDICAL INC 8202 SHERMAN ROAD Chesterland, OH 44026 |
| Contact | Karen E Warden |
| Correspondent | Karen E Warden NEXXT MEDICAL INC 8202 SHERMAN ROAD Chesterland, OH 44026 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-30 |
| Decision Date | 2010-01-19 |
| Summary: | summary |