The following data is part of a premarket notification filed by Custom Spine, Inc. with the FDA for Issys Lp Spinal Fixation System.
| Device ID | K070281 |
| 510k Number | K070281 |
| Device Name: | ISSYS LP SPINAL FIXATION SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | CUSTOM SPINE, INC. 13540 GUILD AVE Apple Valley, MN 55124 |
| Contact | Richard Jansen |
| Correspondent | Richard Jansen CUSTOM SPINE, INC. 13540 GUILD AVE Apple Valley, MN 55124 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| 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 | 2007-01-29 |
| Decision Date | 2007-06-11 |
| Summary: | summary |