The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Matrix System.
| Device ID | K092929 |
| 510k Number | K092929 |
| Device Name: | SYNTHES MATRIX SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Susan Lewandowski |
| Correspondent | Susan Lewandowski 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 | 2009-09-23 |
| Decision Date | 2009-12-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H981096310300 | K092929 | 000 |
| H981096360550 | K092929 | 000 |
| H981096360600 | K092929 | 000 |
| H981096360650 | K092929 | 000 |
| H981096360700 | K092929 | 000 |
| H981096360750 | K092929 | 000 |
| H981096360800 | K092929 | 000 |
| H981096360850 | K092929 | 000 |
| H981096361250 | K092929 | 000 |
| H981046161300 | K092929 | 000 |
| H981046161500 | K092929 | 000 |
| H981096360500 | K092929 | 000 |
| H981096360450 | K092929 | 000 |
| H981096360400 | K092929 | 000 |
| H981096310500 | K092929 | 000 |
| H981096310750 | K092929 | 000 |
| H981096311250 | K092929 | 000 |
| H981096311750 | K092929 | 000 |
| H981096331000 | K092929 | 000 |
| H981096331500 | K092929 | 000 |
| H981096333700 | K092929 | 000 |
| H981096333710 | K092929 | 000 |
| H981096360300 | K092929 | 000 |
| H981096360350 | K092929 | 000 |
| H981046161750 | K092929 | 000 |
| H981046162250 | K092929 | 000 |
| H981046162750 | K092929 | 000 |
| H981046333950 | K092929 | 000 |
| H981046342300 | K092929 | 000 |
| H981046342500 | K092929 | 000 |
| H981046342750 | K092929 | 000 |
| H981046343250 | K092929 | 000 |
| H981046343750 | K092929 | 000 |
| H981046396700 | K092929 | 000 |
| H981046396750 | K092929 | 000 |
| H981046396800 | K092929 | 000 |
| H981046396900 | K092929 | 000 |
| H981046333750 | K092929 | 000 |
| H981046333740 | K092929 | 000 |
| H981046333710 | K092929 | 000 |
| H981046326700 | K092929 | 000 |
| H981046326750 | K092929 | 000 |
| H981046326800 | K092929 | 000 |
| H981046326900 | K092929 | 000 |
| H981046326990 | K092929 | 000 |
| H981046332790 | K092929 | 000 |
| H981046332810 | K092929 | 000 |
| H981046332900 | K092929 | 000 |
| H981046332910 | K092929 | 000 |
| H981046333700 | K092929 | 000 |
| H981046396990 | K092929 | 000 |