The following data is part of a premarket notification filed by Ulrich Gmbh & Co. Kg with the FDA for Tangors Polyaxial System.
Device ID | K052385 |
510k Number | K052385 |
Device Name: | TANGORS POLYAXIAL SYSTEM |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | ULRICH GMBH & CO. KG BUCHBRUNNENWEG 12 Ulm, DE D-89081 |
Contact | Christoph Ulrich |
Correspondent | Christoph Ulrich ULRICH GMBH & CO. KG BUCHBRUNNENWEG 12 Ulm, DE D-89081 |
Product Code | NKB |
Subsequent Product Code | MNH |
Subsequent Product Code | MNI |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-08-30 |
Decision Date | 2005-12-27 |
Summary: | summary |