The following data is part of a premarket notification filed by Neoortho Produtos Ortopedicos S/a with the FDA for Peek Cage For The Vertebral Spine.
| Device ID | K132852 |
| 510k Number | K132852 |
| Device Name: | PEEK CAGE FOR THE VERTEBRAL SPINE |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | NEOORTHO PRODUTOS ORTOPEDICOS S/A 18851 NE 29TH AVE 720 Aventura, FL 33180 |
| Contact | Tara Conrad |
| Correspondent | Tara Conrad NEOORTHO PRODUTOS ORTOPEDICOS S/A 18851 NE 29TH AVE 720 Aventura, FL 33180 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-11 |
| Decision Date | 2014-05-29 |
| Summary: | summary |