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 | K111099 |
| 510k Number | K111099 |
| Device Name: | ISSYS LP SPINAL FIXATION SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | CUSTOM SPINE, INC. 1140 PARSIPPANY BLVD. SUITE 201 Parsippany, NJ 07054 |
| Contact | Saad Attiyah |
| Correspondent | Saad Attiyah CUSTOM SPINE, INC. 1140 PARSIPPANY BLVD. SUITE 201 Parsippany, NJ 07054 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-20 |
| Decision Date | 2011-05-05 |
| Summary: | summary |