The following data is part of a premarket notification filed by Innovative Spinal Technologies Inc with the FDA for Ist Pedicle Screw System.
| Device ID | K053276 |
| 510k Number | K053276 |
| Device Name: | IST PEDICLE SCREW SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | INNOVATIVE SPINAL TECHNOLOGIES INC PO BOX 110 Mansfield, MA 02048 |
| Contact | Stephen Palumbo |
| Correspondent | Stephen Palumbo INNOVATIVE SPINAL TECHNOLOGIES INC PO BOX 110 Mansfield, MA 02048 |
| 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 | 2005-11-23 |
| Decision Date | 2005-12-27 |
| Summary: | summary |