The following data is part of a premarket notification filed by Osteomed Implantes, Ltda with the FDA for Anterior Cervical Plate System.
| Device ID | K151553 |
| 510k Number | K151553 |
| Device Name: | Anterior Cervical Plate System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | Osteomed Implantes, LTDA Washington Luiz Road, Km 172, Condominio Conpark - Rua 6 Rio Claro - Sp, BR 13501-600 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb THE ORTHOMEDIX GROUP, INC 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-09 |
| Decision Date | 2016-02-10 |
| Summary: | summary |