The following data is part of a premarket notification filed by Ulrich Gmbh & Co. Kg with the FDA for Mambo, Model Cs 18xx-xx.
| Device ID | K090861 |
| 510k Number | K090861 |
| Device Name: | MAMBO, MODEL CS 18XX-XX |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | ULRICH GMBH & CO. KG 754 SPIRIT 40 PARK DRIVE Chesterfield, MO 63005 |
| Contact | Merle Symes |
| Correspondent | Merle Symes ULRICH GMBH & CO. KG 754 SPIRIT 40 PARK DRIVE Chesterfield, MO 63005 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-30 |
| Decision Date | 2010-05-21 |
| Summary: | summary |