The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 1.5mm/2.0mm Orthognathic Maxillary Plates And Screws.
| Device ID | K980199 |
| 510k Number | K980199 |
| Device Name: | SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWS |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Contact | Sheri Musgnung |
| Correspondent | Sheri Musgnung SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Product Code | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-20 |
| Decision Date | 1998-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679400806960 | K980199 | 000 |
| H679400820960 | K980199 | 000 |
| H679400822960 | K980199 | 000 |
| H679400824960 | K980199 | 000 |
| H980400034E0 | K980199 | 000 |
| H980400035E0 | K980199 | 000 |
| H980400036E0 | K980199 | 000 |
| H980400038E0 | K980199 | 000 |
| H980400040E0 | K980199 | 000 |
| H679400818960 | K980199 | 000 |
| H679400816960 | K980199 | 000 |
| H679400807960 | K980199 | 000 |
| H679400808960 | K980199 | 000 |
| H679400809960 | K980199 | 000 |
| H679400810960 | K980199 | 000 |
| H679400811960 | K980199 | 000 |
| H679400812960 | K980199 | 000 |
| H679400813960 | K980199 | 000 |
| H679400814960 | K980199 | 000 |
| H980400042E0 | K980199 | 000 |
| H980400044E0 | K980199 | 000 |
| H980400046E0 | K980199 | 000 |
| H980400735E0 | K980199 | 000 |
| H980400737E0 | K980199 | 000 |
| H980400739E0 | K980199 | 000 |
| H980400741E0 | K980199 | 000 |
| H9804200710 | K980199 | 000 |
| 20887587044917 | K980199 | 000 |
| 20887587044955 | K980199 | 000 |
| 20887587044993 | K980199 | 000 |
| H980400288E0 | K980199 | 000 |
| H980400286E0 | K980199 | 000 |
| H980400048E0 | K980199 | 000 |
| H980400274E0 | K980199 | 000 |
| H980400275E0 | K980199 | 000 |
| H980400276E0 | K980199 | 000 |
| H980400278E0 | K980199 | 000 |
| H980400280E0 | K980199 | 000 |
| H980400282E0 | K980199 | 000 |
| H980400284E0 | K980199 | 000 |
| 20887587045037 | K980199 | 000 |