The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Low Profile Neuro System.
| Device ID | K022012 |
| 510k Number | K022012 |
| Device Name: | SYNTHES LOW PROFILE NEURO SYSTEM |
| Classification | Plate, Bone |
| Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Contact | Matthew M Hull |
| Correspondent | Matthew M Hull 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 | 2002-06-20 |
| Decision Date | 2002-11-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H980400834E0 | K022012 | 000 |
| H9804215080 | K022012 | 000 |
| H9804215090 | K022012 | 000 |
| H9804215100 | K022012 | 000 |
| H9804215110 | K022012 | 000 |
| H9804215120 | K022012 | 000 |
| H9804215150 | K022012 | 000 |
| H9804215160 | K022012 | 000 |
| H9804215170 | K022012 | 000 |
| H9804215180 | K022012 | 000 |
| H9804215190 | K022012 | 000 |
| H9804215200 | K022012 | 000 |
| H9804215210 | K022012 | 000 |
| H9804215220 | K022012 | 000 |
| H9804215070 | K022012 | 000 |
| H9804215060 | K022012 | 000 |
| H9804215050 | K022012 | 000 |
| H980400835E0 | K022012 | 000 |
| H980400836E0 | K022012 | 000 |
| H980400844E0 | K022012 | 000 |
| H980400845E0 | K022012 | 000 |
| H980400846E0 | K022012 | 000 |
| H980400854E0 | K022012 | 000 |
| H980400855E0 | K022012 | 000 |
| H980400856E0 | K022012 | 000 |
| H9804215000 | K022012 | 000 |
| H9804215010 | K022012 | 000 |
| H9804215020 | K022012 | 000 |
| H9804215030 | K022012 | 000 |
| H9804215040 | K022012 | 000 |
| H9804215230 | K022012 | 000 |
| H9804215250 | K022012 | 000 |
| H9804215260 | K022012 | 000 |
| H9804215450 | K022012 | 000 |
| H9804215460 | K022012 | 000 |
| H9804215470 | K022012 | 000 |
| H9804008340 | K022012 | 000 |
| H980400834200 | K022012 | 000 |
| H9804008350 | K022012 | 000 |
| H980400835200 | K022012 | 000 |
| H9804008360 | K022012 | 000 |
| H9804008440 | K022012 | 000 |
| H9804008450 | K022012 | 000 |
| H9804008460 | K022012 | 000 |
| H9804008540 | K022012 | 000 |
| H9804008550 | K022012 | 000 |
| H9804215440 | K022012 | 000 |
| H9804215430 | K022012 | 000 |
| H9804215420 | K022012 | 000 |
| H9804215270 | K022012 | 000 |
| H9804215280 | K022012 | 000 |
| H9804215310 | K022012 | 000 |
| H9804215320 | K022012 | 000 |
| H9804215330 | K022012 | 000 |
| H9804215340 | K022012 | 000 |
| H9804215350 | K022012 | 000 |
| H9804215360 | K022012 | 000 |
| H9804215370 | K022012 | 000 |
| H9804215380 | K022012 | 000 |
| H9804215390 | K022012 | 000 |
| H9804215400 | K022012 | 000 |
| H9804215410 | K022012 | 000 |
| H9804008560 | K022012 | 000 |