The following data is part of a premarket notification filed by Sintea Plustek, Llc with the FDA for Sintea Plustek Anterior Cervical Plate System.
| Device ID | K112861 |
| 510k Number | K112861 |
| Device Name: | SINTEA PLUSTEK ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | SINTEA PLUSTEK, LLC 407 LINCOLN ROAD, SUITE 10L Miami Beach, FL 33139 |
| Contact | Danielle Wernikowski |
| Correspondent | Danielle Wernikowski SINTEA PLUSTEK, LLC 407 LINCOLN ROAD, SUITE 10L Miami Beach, FL 33139 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-30 |
| Decision Date | 2012-02-24 |
| Summary: | summary |