The following data is part of a premarket notification filed by Zimmer Spine with the FDA for Instinct Java System.
| Device ID | K111301 |
| 510k Number | K111301 |
| Device Name: | INSTINCT JAVA SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | ZIMMER SPINE 7375 BUSH LAKE ROAD Edina, MN 55439 |
| Contact | Elsa A Linke |
| Correspondent | Elsa A Linke ZIMMER SPINE 7375 BUSH LAKE ROAD Edina, MN 55439 |
| 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 | 2011-05-09 |
| Decision Date | 2011-08-26 |
| Summary: | summary |