The following data is part of a premarket notification filed by Synthes Spine with the FDA for Synthes Mirs.
| Device ID | K113044 |
| 510k Number | K113044 |
| Device Name: | SYNTHES MIRS |
| 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 | 2011-10-12 |
| Decision Date | 2011-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H981046315020 | K113044 | 000 |
| H981046516200 | K113044 | 000 |
| H981046516300 | K113044 | 000 |
| H981046516400 | K113044 | 000 |
| H981046516500 | K113044 | 000 |
| H981046516600 | K113044 | 000 |
| H981046516700 | K113044 | 000 |
| H981046516800 | K113044 | 000 |
| H981046516900 | K113044 | 000 |
| H981046315000 | K113044 | 000 |
| H981046516100 | K113044 | 000 |