The following data is part of a premarket notification filed by Biedermann Motech Gmbh & Co. Kg with the FDA for Moss Vrs Spinal System.
| Device ID | K203607 |
| 510k Number | K203607 |
| Device Name: | MOSS VRS Spinal System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Biedermann Motech GmbH & Co. KG Bertha-von Suttner-Strasse 23 Villingen-schwenningen, DE 78054 |
| Contact | Gerd Federle |
| Correspondent | Gerd Federle Biedermann Motech GmbH & Co. KG Bertha-von Suttner-Strasse 23 Villingen-schwenningen, DE 78054 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-10 |
| Decision Date | 2021-08-20 |