The following data is part of a premarket notification filed by Ulrich Gmbh & Co. Kg with the FDA for Small Vbr™.
Device ID | K192117 |
510k Number | K192117 |
Device Name: | Small VBR™ |
Classification | Spinal Vertebral Body Replacement Device |
Applicant | ulrich GmbH & Co. KG Buchbrunnenweg 12 Ulm, DE 89081 |
Contact | Christoph Ulrich |
Correspondent | Hans Stover ulrich Medical USA 18221 Edison Avenue Chesterfield, MO 63005 |
Product Code | MQP |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-08-06 |
Decision Date | 2019-11-01 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04052536009510 | K192117 | 000 |
04052536009503 | K192117 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SMALL VBR 88262022 not registered Live/Pending |
Ulrich Medical USA Inc. 2019-01-15 |