The following data is part of a premarket notification filed by Icotec Ag with the FDA for Icotec Pedicle System.
| Device ID | K151977 |
| 510k Number | K151977 |
| Device Name: | Icotec Pedicle System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | ICOTEC AG INDUSTRIESTRASSE 12 Altstaetten, SE 9450 |
| Contact | Jorg Schneider |
| Correspondent | Samuel Pollard Musculoskeletal Clinical Regulatory Advisers, LLC 1331 H Street Northwest 12th Floor Washington, DC 20005 |
| Product Code | NKB |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-17 |
| Decision Date | 2016-04-12 |
| Summary: | summary |