The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Matrix System.
| Device ID | K100634 |
| 510k Number | K100634 |
| Device Name: | SYNTHES MATRIX SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Amnon Talmor |
| Correspondent | Amnon Talmor 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 | 2010-03-05 |
| Decision Date | 2010-07-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H981046332300 | K100634 | 000 |
| H981046332250 | K100634 | 000 |
| H981046332200 | K100634 | 000 |
| H981046332150 | K100634 | 000 |
| H981046331880 | K100634 | 000 |
| H981046331870 | K100634 | 000 |
| H981SD096331870 | K100634 | 000 |
| H981096331870 | K100634 | 000 |