The following data is part of a premarket notification filed by Custom Spine, Inc. with the FDA for Issys Pedicle Screw System.
| Device ID | K043522 |
| 510k Number | K043522 |
| Device Name: | ISSYS PEDICLE SCREW SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | CUSTOM SPINE, INC. PO BOX 1070 Conway, NH 03818 |
| Contact | Debbie Iampietro |
| Correspondent | Debbie Iampietro CUSTOM SPINE, INC. PO BOX 1070 Conway, NH 03818 |
| Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-20 |
| Decision Date | 2005-01-14 |
| Summary: | summary |