The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) [synthes] Mmfs - 2.0 Mm Sagittal Split Plates.
Device ID | K981890 |
510k Number | K981890 |
Device Name: | SYNTHES (USA) [SYNTHES] MMFS - 2.0 MM SAGITTAL SPLIT PLATES |
Classification | Plate, Bone |
Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
Contact | Sheri L Musgnung |
Correspondent | Sheri L Musgnung SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
Product Code | JEY |
CFR Regulation Number | 872.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-05-29 |
Decision Date | 1998-08-18 |
Summary: | summary |