The following data is part of a premarket notification filed by Ulrich Gmbh & Co. Kg with the FDA for Cosmic System.
| Device ID | K080841 |
| 510k Number | K080841 |
| Device Name: | COSMIC SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | ULRICH GMBH & CO. KG 754 SPIRIT 40 PARK DRIVE St. Louis, MO 63005 |
| Contact | Merle Symes |
| Correspondent | Merle Symes ULRICH GMBH & CO. KG 754 SPIRIT 40 PARK DRIVE St. Louis, MO 63005 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-26 |
| Decision Date | 2008-07-23 |
| Summary: | summary |