The following data is part of a premarket notification filed by Synthes Spine with the FDA for Synthes Matrix System.
Device ID | K120928 |
510k Number | K120928 |
Device Name: | SYNTHES MATRIX SYSTEM |
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 | 2012-03-27 |
Decision Date | 2012-05-18 |
Summary: | summary |