The following data is part of a premarket notification filed by Sintea Plastek, Llc with the FDA for Sintea Plustek Pls Multi-axial Screws.
| Device ID | K112611 |
| 510k Number | K112611 |
| Device Name: | SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | SINTEA PLASTEK, LLC 407 LINCOLN ROAD SUITE 10L Miami Beach, FL 33139 |
| Contact | Danielle Wernikowski |
| Correspondent | Danielle Wernikowski SINTEA PLASTEK, LLC 407 LINCOLN ROAD SUITE 10L Miami Beach, FL 33139 |
| Product Code | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-07 |
| Decision Date | 2012-04-25 |
| Summary: | summary |