The following data is part of a premarket notification filed by Osteomed Implantes, Ltda with the FDA for Dpz Pedicular Fixation System.
| Device ID | K150294 |
| 510k Number | K150294 |
| Device Name: | DPZ Pedicular Fixation System |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | Osteomed Implantes, LTDA Washington Luiz Road, Km 172, Condominio Conpark - Rua 6 Rio Claro, BR 13501-600 |
| Contact | J. D. Webb |
| Correspondent | J. D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Boulevard Round Rock, TX 78681 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-06 |
| Decision Date | 2015-06-05 |
| Summary: | summary |