The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Matrix Mis Rods.
| Device ID | K093668 |
| 510k Number | K093668 |
| Device Name: | SYNTHES MATRIX MIS RODS |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Heather Guerin |
| Correspondent | Heather Guerin SYNTHES (USA) 1302 WRIGHTS LANE 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 | 2009-11-27 |
| Decision Date | 2010-03-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H981046516000 | K093668 | 000 |
| H981046512750 | K093668 | 000 |
| H981046512700 | K093668 | 000 |
| H981046512650 | K093668 | 000 |
| H981046512600 | K093668 | 000 |
| H981046512550 | K093668 | 000 |
| H981046510850 | K093668 | 000 |
| H981046510800 | K093668 | 000 |
| H981046510750 | K093668 | 000 |
| H981046510700 | K093668 | 000 |
| H981046510650 | K093668 | 000 |
| H981046510600 | K093668 | 000 |
| H981046510550 | K093668 | 000 |
| H981046510500 | K093668 | 000 |
| H981046510450 | K093668 | 000 |
| H981046510400 | K093668 | 000 |
| H981046512800 | K093668 | 000 |
| H981046512850 | K093668 | 000 |
| H981046512900 | K093668 | 000 |
| H981046515900 | K093668 | 000 |
| H981046515800 | K093668 | 000 |
| H981046515700 | K093668 | 000 |
| H981046515600 | K093668 | 000 |
| H981046515500 | K093668 | 000 |
| H981046515400 | K093668 | 000 |
| H981046515300 | K093668 | 000 |
| H981046513300 | K093668 | 000 |
| H981046513250 | K093668 | 000 |
| H981046513200 | K093668 | 000 |
| H981046513150 | K093668 | 000 |
| H981046513100 | K093668 | 000 |
| H981046513050 | K093668 | 000 |
| H981046513000 | K093668 | 000 |
| H981046512950 | K093668 | 000 |
| H981046510350 | K093668 | 000 |