The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Nuvasive Decade Lateral Plate System.
| Device ID | K130868 |
| 510k Number | K130868 |
| Device Name: | NUVASIVE DECADE LATERAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | NUVASIVE, INC. 7475 LUSK BLVD San Diego, CA 92121 |
| Contact | Cynthia Adams |
| Correspondent | Cynthia Adams NUVASIVE, INC. 7475 LUSK BLVD San Diego, CA 92121 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-29 |
| Decision Date | 2013-08-29 |
| Summary: | summary |