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 | K181821 |
510k Number | K181821 |
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 | 2018-07-09 |
Decision Date | 2018-09-13 |
Summary: | summary |