The following data is part of a premarket notification filed by Sintea Plastek, Llc with the FDA for Dsc/alf Spinal System.
| Device ID | K101886 |
| 510k Number | K101886 |
| Device Name: | DSC/ALF SPINAL SYSTEM |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | SINTEA PLASTEK, LLC 407 LINCOLN ROAD SUITE 101 Miami Beach, FL 33139 |
| Contact | Danielle Wernikowski |
| Correspondent | Danielle Wernikowski SINTEA PLASTEK, LLC 407 LINCOLN ROAD SUITE 101 Miami Beach, FL 33139 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-06 |
| Decision Date | 2011-07-21 |
| Summary: | summary |