The following data is part of a premarket notification filed by Signus Medizintechnik Gmbh with the FDA for Ovaltwist Pedicle Screw System.
| Device ID | K061577 |
| 510k Number | K061577 |
| Device Name: | OVALTWIST PEDICLE SCREW SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | SIGNUS MEDIZINTECHNIK GMBH 681 WEST 2760 NORTH Pleasant Grove, UT 84062 |
| Contact | Mike Ensign |
| Correspondent | Mike Ensign SIGNUS MEDIZINTECHNIK GMBH 681 WEST 2760 NORTH Pleasant Grove, UT 84062 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-07 |
| Decision Date | 2006-09-14 |