The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Modification To Synthes Cranial Plates.
Device ID | K042987 |
510k Number | K042987 |
Device Name: | MODIFICATION TO SYNTHES CRANIAL PLATES |
Classification | Plate, Bone |
Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
Contact | Lisa M Boyle |
Correspondent | Lisa M Boyle SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
Product Code | JEY |
CFR Regulation Number | 872.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-10-29 |
Decision Date | 2004-11-23 |
Summary: | summary |