The following data is part of a premarket notification filed by Neoortho Productos Orthopedicos S/a with the FDA for Neoplate Spine Anterior Fixation System.
| Device ID | K132653 |
| 510k Number | K132653 |
| Device Name: | NEOPLATE SPINE ANTERIOR FIXATION SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | NEOORTHO PRODUCTOS ORTHOPEDICOS S/A 18851 NE 29TH AVE 720 Aventura, FL 33180 |
| Contact | Tara Conrad |
| Correspondent | Tara Conrad NEOORTHO PRODUCTOS ORTHOPEDICOS S/A 18851 NE 29TH AVE 720 Aventura, FL 33180 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-26 |
| Decision Date | 2014-05-14 |
| Summary: | summary |