The following data is part of a premarket notification filed by Synthes Inc with the FDA for Synthes Matrixmadible Plate And Screw System.
Device ID | K113567 |
510k Number | K113567 |
Device Name: | SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM |
Classification | Plate, Bone |
Applicant | SYNTHES INC 1301 Goshen Parkway West Chester, PA 19380 |
Contact | Alan T Haley |
Correspondent | Alan T Haley SYNTHES INC 1301 Goshen Parkway West Chester, PA 19380 |
Product Code | JEY |
CFR Regulation Number | 872.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-12-02 |
Decision Date | 2012-11-19 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H980045037890 | K113567 | 000 |
H980045037880 | K113567 | 000 |
H980045037870 | K113567 | 000 |
H980045037860 | K113567 | 000 |
H980045037850 | K113567 | 000 |