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 |
| 04052536219605 | K192117 | 000 |
| 04052536219599 | K192117 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SMALL VBR 88262022 not registered Live/Pending |
Ulrich Medical USA Inc. 2019-01-15 |