The following data is part of a premarket notification filed by Synthes with the FDA for Synthes Matrixneuro Cranial Plating System.
Device ID | K123723 |
510k Number | K123723 |
Device Name: | SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM |
Classification | Plate, Cranioplasty, Preformed, Alterable |
Applicant | SYNTHES 1301 Goshen Parkway West Chester, PA 19380 |
Contact | Alan T Haley |
Correspondent | Alan T Haley SYNTHES 1301 Goshen Parkway West Chester, PA 19380 |
Product Code | GWO |
CFR Regulation Number | 882.5320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-12-04 |
Decision Date | 2013-09-05 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H98004503150S0 | K123723 | 000 |
H98004503149S0 | K123723 | 000 |
H98004503147S0 | K123723 | 000 |
H98004503146S0 | K123723 | 000 |
H98004503145S0 | K123723 | 000 |