The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Neuro Plate And Screw System.
| Device ID | K042365 |
| 510k Number | K042365 |
| Device Name: | SYNTHES (USA) NEURO PLATE AND SCREW SYSTEM |
| Classification | Plate, Bone |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-31 |
| Decision Date | 2004-11-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H980045030820 | K042365 | 000 |
| H980045030670 | K042365 | 000 |
| H980045030660 | K042365 | 000 |
| H980045030650 | K042365 | 000 |
| H980045030640 | K042365 | 000 |
| H980045030630 | K042365 | 000 |
| H980045030620 | K042365 | 000 |
| H980045030610 | K042365 | 000 |
| H980045030570 | K042365 | 000 |
| H980045030560 | K042365 | 000 |
| H980045030680 | K042365 | 000 |
| H980045030690 | K042365 | 000 |
| H980045030810 | K042365 | 000 |
| H980045030770 | K042365 | 000 |
| H980045030760 | K042365 | 000 |
| H980045030750 | K042365 | 000 |
| H980045030740 | K042365 | 000 |
| H980045030730 | K042365 | 000 |
| H980045030720 | K042365 | 000 |
| H980045030710 | K042365 | 000 |
| H980045030700 | K042365 | 000 |
| H980045030290 | K042365 | 000 |
| H980045030280 | K042365 | 000 |
| H980045030270 | K042365 | 000 |
| H980045020620 | K042365 | 000 |
| H980045020610 | K042365 | 000 |
| H980045020280 | K042365 | 000 |
| H980045020240 | K042365 | 000 |
| H980045020230 | K042365 | 000 |
| H980045020220 | K042365 | 000 |
| H980045020210 | K042365 | 000 |
| H980SD4220090 | K042365 | 000 |
| H980SD4220020 | K042365 | 000 |
| H980045020630 | K042365 | 000 |
| H980045020640 | K042365 | 000 |
| H980045030260 | K042365 | 000 |
| H980045030240 | K042365 | 000 |
| H980045030230 | K042365 | 000 |
| H980045030220 | K042365 | 000 |
| H980045030210 | K042365 | 000 |
| H980045020740 | K042365 | 000 |
| H980045020730 | K042365 | 000 |
| H980045020680 | K042365 | 000 |
| H980045020650 | K042365 | 000 |
| H980SD4220010 | K042365 | 000 |
| H980045030830 | K042365 | 000 |
| H98004503115200 | K042365 | 000 |
| H98004503134S0 | K042365 | 000 |
| H98004503131S0 | K042365 | 000 |
| H980045031270 | K042365 | 000 |
| H980045031260 | K042365 | 000 |
| H980045031250 | K042365 | 000 |
| H980045031240 | K042365 | 000 |
| H980045031230 | K042365 | 000 |
| H98004503122S0 | K042365 | 000 |
| H980045031220 | K042365 | 000 |
| H98004503103050 | K042365 | 000 |
| H98004503103200 | K042365 | 000 |
| H98004503115050 | K042365 | 000 |
| H98004503114200 | K042365 | 000 |
| H98004503114050 | K042365 | 000 |
| H98004503113200 | K042365 | 000 |
| H98004503113050 | K042365 | 000 |
| H98004503105200 | K042365 | 000 |
| H98004503105050 | K042365 | 000 |
| H98004503104200 | K042365 | 000 |
| H98004503104050 | K042365 | 000 |
| H980045031210 | K042365 | 000 |
| H980045031200 | K042365 | 000 |
| H98004503115010 | K042365 | 000 |
| H980045030920 | K042365 | 000 |
| H980045030910 | K042365 | 000 |
| H980045030900 | K042365 | 000 |
| H980045030890 | K042365 | 000 |
| H980045030880 | K042365 | 000 |
| H980045030870 | K042365 | 000 |
| H980045030860 | K042365 | 000 |
| H98004503085S0 | K042365 | 000 |
| H980045030850 | K042365 | 000 |
| H980045030930 | K042365 | 000 |
| H980045030940 | K042365 | 000 |
| H98004503114010 | K042365 | 000 |
| H98004503113010 | K042365 | 000 |
| H98004503105010 | K042365 | 000 |
| H98004503104010 | K042365 | 000 |
| H98004503103010 | K042365 | 000 |
| H980045030980 | K042365 | 000 |
| H980045030970 | K042365 | 000 |
| H980045030960 | K042365 | 000 |
| H980045030950 | K042365 | 000 |
| H980045030840 | K042365 | 000 |