The following data is part of a premarket notification filed by Osteomed Implantes, Ltda with the FDA for Intersomatic Cervical Device - Dicom Peek, Intersomatic Intervertebral Space Maintenance Device - Dimei Peek, Intersomatic Transforaminal - Tlif Peek.
| Device ID | K143572 |
| 510k Number | K143572 |
| Device Name: | Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, Intersomatic Transforaminal - TLIF PEEK |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | Osteomed Implantes, LTDA Washington Luiz Road, Km 172, Condominio Conpark - Rua 6 Rio Claro, BR 13501-600 |
| Contact | Niderdani Ragonha |
| Correspondent | J.d. Webb THE ORTHOMEDIX GROUP, INC 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-17 |
| Decision Date | 2015-06-10 |
| Summary: | summary |