The following data is part of a premarket notification filed by Synthes Spine with the FDA for Synthes Uss.
| Device ID | K111358 |
| 510k Number | K111358 |
| Device Name: | SYNTHES USS |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | SYNTHES SPINE 1302 WRIGHTS LN EAST West Chester, PA 19380 |
| Contact | Heather Guerin |
| Correspondent | Heather Guerin SYNTHES SPINE 1302 WRIGHTS LN EAST West Chester, PA 19380 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-16 |
| Decision Date | 2011-11-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H981046334050 | K111358 | 000 |
| H981046334040 | K111358 | 000 |
| H981046334030 | K111358 | 000 |
| H981046334020 | K111358 | 000 |
| H981046334010 | K111358 | 000 |
| H981046334000 | K111358 | 000 |